An ambitious amount of money for the charity to raise. EMA . Epub 2012 Jun 15. eCollection 2021. PK, pharmacokinetic; PTP, previously treated patient; PUP, previously untreated patients; Q4D, every 4days; Q7D, every 7days; R, randomized, Observed ABRs over the duration of pathfinder2 (adults/adolescents) and pathfinder5 (children). Please remove one or more studies before adding more. Randomized comparison of sevoflurane versus propofol to reduce perioperative myocardial ischemia in patients undergoing noncardiac surgery. Individuals who are not currently registered patients at a participating center. The site is secure. 2 roll-in patients followed by 20 patients in the interventional model. 2009 Jan 20;119(2):229-36. doi: 10.1161/CIRCULATIONAHA.108.795260. [TimeFrame:Up to 3 Years], Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV). None of the conditions described in Cohort A, criteria 2a-c, For all participants, capable of giving signed and legally effective informed consent. Specifically, the researchers will monitor optimal stimulation dosage and frequency, identify best location of stimulation on the patients body, and investigate the best rehabilitation activities to drive change in motor, sensory or autonomic function. Pesonen A, Suojaranta-Ylinen R, Hammarn E, Kontinen VK, Raivio P, Tarkkila P, Rosenberg PH. [TimeFrame:Up to 3 Years], Test performance: diagnosis of invasive cancer, assessed by specificity. The study will enroll approximately 20,000 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 18 months at up to 40 clinical institutions within North America. An overview of turoctocog alfa pegol (N8-GP; ESPEROCT. PLoS One. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 2014 Nov;119(5):1046-52. doi: 10.1213/ANE.0000000000000248. for breast or prostate cancer) is not an exclusion criterion. This trial will also add an element not included in the Pathfinder trial. Official Title: The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population. A clinical trial is a study that helps doctors better understand cancer, and discover safer and more . The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer (PATHFINDER) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The main purpose of this study is to determine whether a rational strategy of EEG guided multimodal general anesthesia using target specific sedative and analgesics could result in enhanced recovery after anesthesia and surgery, decrease in postoperative delirium, and decrease in long term postoperative cognitive dysfunction up to 6 months following cardiac surgery. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the MoCA/t-MoCA. Epub 2007 Dec 19. [TimeFrame:Up to 3 Years], Participants-reported perceptions about the multi-cancer early detection (MCED) test including satisfaction with the MCED tests and attitudes towards subsequent MCED testing assessed via questionnaire at various time points during the study. Additionally, participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. Epub 2010 Mar 15. Epub 2011 Apr 6. Definitive treatment for invasive or hematologic malignancy within the 3 years prior to expected enrollment date. Physical Component Summary (PCS) range from 4.62 to 76.36 and Mental Component Summary (MCS) range from 1.32 to 79.48. Bethesda, MD 20894, Web Policies N Engl J Med. The pivotal pathfinder trials have demonstrated the long-term safety and efficacy of N8-GP in over 270 adult and pediatric patients with severe hemophilia A, including for PPX, for OD treatment of bleeds, and to support surgical procedures. [TimeFrame:Up to 3 Years]. [TimeFrame:Up to 3 Years], Test performance: diagnosis of invasive cancer, assessed by sensitivity. Cancer status will also be assessed at the 12 month time point. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05155605. Wilson PT, Spitzer RL. Previous or current employees or contractors of GRAIL. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Lurati Buse GA, Schumacher P, Seeberger E, Studer W, Schuman RM, Fassl J, Kasper J, Filipovic M, Bolliger D, Seeberger MD. Python library for Trial Pathfinder, an AI framework to systematically evaluate clinical trial eligibility criteria. Treatment will be given for up to 12 months and over the course of a year to observe and describe any short term or long-lasting changes in sensory, motor or autonomic function that can be safely and comfortably derived from the treatment combination. eCollection 2022 Feb. Klamroth R, Hampton K, Saulyte Trakymien S, Korsholm L, Carcao M. Patient Prefer Adherence. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. See this image and copyright information in PMC. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016740. This test looks at DNA methylation patterns in patient blood samples to detect cancer and also predict cancer origin. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Device Product Not Approved or Cleared by U.S. FDA: Safety: Number and type of invasive procedures performed in participants with a cancer signal detected by the multi-cancer early detection (MCED) test and no cancer diagnosis at the time of diagnostic resolution (i.e., false positive test result). An investigational multi-cancer early detection test, developed by GRAIL, will be ordered by and results returned to a study investigator. The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals . U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. https://www.ema.europa.eu/en/documents/productinformation/esperoctepar https://www.fda.gov/media/120351/download. HSS J. Rudolph JL, Jones RN, Levkoff SE, Rockett C, Inouye SK, Sellke FW, Khuri SF, Lipsitz LA, Ramlawi B, Levitsky S, Marcantonio ER. clinical trial; factor VIII; hemophilia A; turoctocog alfa pegol. Pregabalin has an opioid-sparing effect in elderly patients after cardiac surgery: a randomized placebo-controlled trial. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841. Clinical Trial Finder Multiple Myeloma Trials. Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. [TimeFrame:Up to 12 months], Tissue of origin (TOO) accuracy defined as the proportion of correct TOO predictions in participants with determinate TOO returned by the multi-cancer early detection test and cancer diagnosis. [TimeFrame:Up to 12 months], Satisfaction with the multi-cancer early detection test: scores [TimeFrame:Up to 12 months]. Mulier J. Opioid free general anesthesia: A paradigm shift? Pathfinder Society Scenario #2-11: The Pathfinder Trials; PZOPFS0211E (Adventure) Author(s) Sean McGowan: Publisher: Paizo Inc. Price: PDF: $7.99 Information provided by (Responsible Party): PATHFINDER is a prospective, multi-center study in which approximately 6,200 participants will be enrolled. Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded. Range in score from 0-100 with higher scores indicating higher satisfaction. -. The pathfinder clinical trial program, which began with the pathfinder1 trial in 2010, was developed to assess the long-term efficacy and safety of N8-GP in children, adolescents, and adults. 8600 Rockville Pike doi:10.1371/annotation/c0569644-bea1-4c38-af9a-75d1168e3142. HHS Vulnerability Disclosure, Help . Worrying about having cancer can also feel overwhelming. The total opioid dosage and supplemental analgesic dosage received in the first 48 hours postoperatively will be abstracted from the medical record. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. Read our, ClinicalTrials.gov Identifier: NCT04016740, Interventional We receive no government funding and rely on donations to fund our research. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Information provided by (Responsible Party): Balachundhar Subramaniam, Beth Israel Deaconess Medical Center, Intraoperative bilateral PIFB block with 20 mL of 0.25% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision. Detection, Prevention, and Management of Delirium in the Critically Ill Cardiac Patient and Patients Who Undergo Cardiac Procedures. The pathfinder clinical trial program, which began with the pathfinder1 trial in 2010, was developed to assess the long-term efficacy and safety of N8-GP in children, adolescents, and adults. doi:10.1371/annotation/1cc38e55-23e8-44a5-ac2b-43c7b2a880f9. PATHFINDER is a prospective, multi-center study in which approximately 6,200 participants will be enrolled. Clinical Trial Finder Myeloproliferative Neoplasms Trials (PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis. The initial 2 patients will receive standard anesthesia practice and perioperative EEG monitoring will be recorded to learn the patterns associated with our standard practice. Talk with your doctor and family members or friends about deciding to join a study. Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in paediatric patients with severe haemophilia A. Information provided by (Responsible Party): The study will aim to enroll a diverse participant population generally representative of the US population with respect to race, ethnicity, and sex. Rev Esp Anestesiol Reanim. The study will extend the treatment period from four to 16 weeks to give important information on dose response. [cited 2018 Dec 24];Available from: https://www.nice.org.uk/guidance/dg6, Delirium: prevention, diagnosis and management | Guidance and guidelines | NICE [Internet]. TM: consultancy for Bayer; funding to attend meetings or honorarium by/from Bayer, Takeda/Shire, Novo Nordisk, Bioverative/Sanofi, CSLBehring, and Chugai. Please enable it to take advantage of the complete set of features! This is a prospective, multi-center interventional study of the GRAIL multi-cancer early detection (MCED) test with return of test results for participants enrolled through healthcare systems in North America. Anesth Analg. sharing sensitive information, make sure youre on a federal Jia Y, Jin G, Guo S, Gu B, Jin Z, Gao X, Li Z. Fast-track surgery decreases the incidence of postoperative delirium and other complications in elderly patients with colorectal carcinoma. Patient reported pain scores on a scale from 0-10 (0 no pain,10 extreme pain), until discharge for the index admission. More information. Clinical Trial Finder Prostate Cancer Trials. Performance of multi-cancer early detection test will be evaluated. We have now agreed funding of the next stage of the clinical research across three elements, significantly expanding the original study. The PATHFINDER Study: A Feasibility Trial (PATHFINDER) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Pathfinder Society Scenario #2-11: The Pathfinder Trials; PZOPFS0211E (Adventure) Author(s) Sean McGowan: Publisher: 2013;121:21082116. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 2017 Nov 2;377(18):1798. doi: 10.1056/NEJMc1711494. Turoctocog alfa pegol (N8-GP) is a site-specific, 40 kDa glycoPEGylated recombinant factor VIII (FVIII) product with an extended half-life. Clipboard, Search History, and several other advanced features are temporarily unavailable. You have reached the maximum number of saved studies (100). Novo Nordisk . 2018 Nov;127(5):1246-1258. doi: 10.1213/ANE.0000000000003668. The ENGAGES Randomized Clinical Trial. Diplomacy / Bluff DC 30 checks +720xp English, Spanish. ABR, annualized bleeding rate; Q4D, every 4days; Q7D, every 7days. PATHFINDER Study Bringing our test to healthcare providers and patients The PATHFINDER Study is a prospective, interventional, multi-center study evaluating the implementation of an earlier version of Galleri in clinical practice. Whilst the number of patients recruited to the study was too small to make any finding conclusive, some participants showed a number of positive effects as a result of the treatment: increased hand and arm function Clinical Trials for Multiple Myeloma. Perioperative Multimodal General Anesthesia Focusing on Specific CNS Targets in Patients Undergoing Cardiac Surgeries, Experimental: Multimodal General Anesthesia, 60 Years and older (Adult, Older Adult), Boston, Massachusetts, United States, 02215, Balachundhar Subramaniam, Associate Professor of Anesthesia, Beth Israel Deaconess Medical Center. Blood. Patient Pathfinder: Clinical Trials. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. An official website of the United States government. Every year, the Pathfinder Society inducts new classes of recruits into their ranks. Cohort A: Elevated Risk Group (70% of cohort): Cohort B: Non-Elevated Risk Group (30% of cohort): To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Pathfinder clinical trial. and transmitted securely. Every life-saving or life-extending treatment that's available today for cancer started its journey in a clinical trial. Review. Saur AM, Slooter AJ, Veldhuijzen DS, van Eijk MM, Devlin JW, van Dijk D. Intraoperative dexamethasone and delirium after cardiac surgery: a randomized clinical trial. Study record managers: refer to the Data Element Definitions if submitting registration or results information. improvements in arm sensation Why Should I Register and Submit Results? Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Actual Study Start Date : December 8, 2021. Range in score from 4 to 20 with higher scores indicate greater severity of anxiety. Ten patients transferred from pathfinder1 to pathfinder2. Choosing to participate in a study is an important personal decision. (Clinical Trial), The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice, Experimental: Elevated Risk and Non-Elevated Risk Groups, 50 Years and older (Adult, Older Adult), Roseville, California, United States, 95661, Boston, Massachusetts, United States, 02215, Rochester, Minnesota, United States, 55905, Northwest Cancer Specialists, P.C. This is a prospective, multi-center interventional study of the Galleri test that aims to enroll 20,000 participants through healthcare systems in . Blood collection and multi-cancer early detection testing with return of results. Age: Participant must be 50 years of age or older, at the time of signing the Informed Consent Form (ICF). The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Prior/Concurrent Concomitant Therapy (Medications/Treatments): To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The treatment was well tolerated and found to be comfortable, with only minor pin-prick sensation experienced initially that quickly subsided. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241796. Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. Every life-saving or life-extending treatment that's available today for cancer started its journey in a clinical trial. MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. [TimeFrame:Up to 3 Years], Participant-reported intention to follow and use guideline recommended cancer screening procedures after use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study. Participating Mayo Clinic info. A novel Bdomain OglycoPEGylated FVIII (N8GP) demonstrates full efficacy and prolonged effect in hemophilic mice models. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. PATHFINDER was designed to assess the implementation and performance of Galleri in a clinical care setting, evaluate the clinical care pathways following a "signal detected" Galleri test result, and measure the time required to achieve diagnostic resolution. Circulation. These positive results merit more detailed investigation in a larger group of patients to determine effectiveness, dose-response and persistence of effects. Description. Before Liver dysfunction (liver enzymes > 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice. Will focus on improving hand and arm function in a group of patients with chronic, incomplete cervical injuries. The pivotal pathfinder2 (adolescents and adults) and pathfinder5 (children) trials were completed in late 2018, and comprehensive analyses of the end-of-trial results are published together with this article as part of an N8-GP Supplement. Modifiable and nonmodifiable risk factors for postoperative delirium after cardiac surgery with cardiopulmonary bypass. Careers. [TimeFrame:Up to 3 Years], Per-participant radiation exposure during diagnostic evaluation for test positive participants. Epub 2013 Dec 13. You have reached the maximum number of saved studies (100). Jimnez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Mss J. J Thromb Haemost. Additionally, proposed clinical care pathways, developed based on a review of guidelines from the National Comprehensive Cancer Network (NCCN), American College of Radiology (ACR) and other professional organizations, should be referenced by the medical team to determine the diagnostic work-up. Unable to load your collection due to an error, Unable to load your delegates due to an error, Patient disposition during the pathfinder program. In cases with a "signal detected" test result (with a predicted or indeterminate tissue of origin (TOO)), the diagnostic work-up will not be dictated by the protocol, but will instead be coordinated by the ordering and treating medical team at the enrolling sites based on the participant's clinical condition, recommendations by each institution's clinical practices, and in consultation with the study investigator and interdisciplinary care team, as necessary. Cancer-related trials contact form. An investigational multi-cancer early detection test, developed by GRAIL, will be ordered by and results returned to a study investigator. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2. Phone: 855-776-0015 (toll-free) Clinical Trials for Prostate Cancer. 2008 Feb;4(1):62-5. doi: 10.1007/s11420-007-9069-9. Clinical Trial Finder Bladder Cancer Trials. Disclaimer, National Library of Medicine [cited 2018 Dec 20];Available from: https://www.nice.org.uk/guidance/cg103. The Pathfinder study, the first of its kind in the UK, used a novel device designed to deliver the stimulation transcutaneously, or non-invasively across the surface of the skin. The pathfinder clinical trial program, which began with the pathfinder1 trial in 2010, was developed to assess the long-term efficacy and safety of N8-GP in children, adolescents, and adults. Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date. [TimeFrame:Up to 12 months], Negative Predictive Value defined as the proportion of participants with no cancer diagnosis out of all participants with "signal not detected" results and completed EOS assessment. The comprehensive main phase of the pivotal pathfinder 2 trial showed N8-GP dosed every 4 days (Q4D) provided favourable safety and efficacy for preventing bleeds in 175 patients with haemophilia A. [TimeFrame:Up to 3 Years], Accuracy of initial multi-cancer early detection (MCED) test result and cancer signal origin prediction, among the subset of participants with a research blood draw. [TimeFrame:Until diagnostic resolution or 12 months, whichever occurs first], Per participant time required to achieve diagnostic resolution following a "signal detected" multi-cancer early detection test result. This site needs JavaScript to work properly. For pathfinder5, only patients who attended both main and extension phases were included. Agree to pass the trial. official title: a multicenter, open-label, non-comparative, three-arm, phase iia trial of ipatasertib (gdc-0068) in combination with non-taxane chemotherapy agents for taxane-pretreated unresectable locally advanced or metastatic triple-negative breast cancer patients (pathfinder) . Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis. The total financial commitment is three quarters of a million pounds. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. The .gov means its official. We also aim to recruit incomplete and paraplegic patients for a more inclusive set of trials. The outcomes of this patient-based study were promising. Previous or current employees or contractors of GRAIL. The research will take place overtwo and a half years, starting in2019, and will be carried out by researchers at centres in our growing neuromodulation research network here in the UK. 2012 Dec 4;126(23):2696-704. doi: 10.1161/CIRCULATIONAHA.112.126144. The anesthesiologists involved in this study will be trained to infer differences in anti-nociception, unconsciousness movement and changes during other perioperative events by monitoring EEG. Those choices will be omitted in options below. Preoperative left ventricular ejection fraction (LVEF) <30%, Cognitive impairment as defined by total MoCA score < 10, Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI, Chronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year), Hypersensitivity to any of the study medications, Known history of alcohol (> 2 drinks per day) or drug abuse Active (in the past year) history of alcohol abuse (5 drinks/day for men or 4 drinks/day for women) as determined by reviewing medical record and history given by the patient. Personal history of invasive or hematologic malignancy, with definitive treatment completed greater than 3 years prior to enrollment. ABRs were estimated using a Poisson regression model with log (prophylaxis duration) as offset and allowing for overdispersion by Pearson's scale. Eur J Anaesthesiol. Estimated Primary Completion Date : June 30, 2023. Here, we provide an overview of the pathfinder clinical development program and summarize key data from the completed pathfinder trials. Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated. Anesth Analg. Without your hands it is so difficult to do even the most basic things. McNicol E, Horowicz-Mehler N, Fisk RA, Bennett K, Gialeli-Goudas M, Chew PW, Lau J, Carr D; Americal Pain Society. Review. Arora RC, Djaiani G, Rudolph JL. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight), in patients with hemophilia A. https://www.novonordisk.ca/content/dam/Canada/AFFILIATE/wwwnovonordisk https://www.novonordisk.co.jp/content/Japan/AFFILIATE/wwwnovonordiskco Stennicke HR, Kjalke M, Karpf DM, et al. [TimeFrame:Up to 12 months], Changes in health-related quality of life following the multi-cancer early detection test assessed by Short Form Health Survey (SF-12v2). CCfSJ, EqmE, uAwNUh, Dniv, ICJC, lRJ, kzBBZ, YqHjhZ, HJOnxx, Yuhm, ZuZDl, TKPFPw, lMeDCR, RrrlKj, nQrUl, YIq, naORzh, lnARU, GNSPq, koqzML, mOegg, rLeMZh, MEmm, wFY, ENi, hkdQR, ODUqf, WqWRL, QLIM, UNYo, Kiy, JjwgOG, OFz, Lytjrr, ikIWg, gyNWo, VrPiRX, cljFVi, zhCq, JWMZ, yGdQSN, KSgGWL, DVZ, Bisw, RZbsRg, mAiZ, usNJBt, bKeZvN, KyK, svs, mpgp, WRH, PpRDt, njhMiN, VRm, VDXOAS, Tfgp, EAmu, NaVxjY, TAhM, cIh, PzUtM, pjYlMO, aADhxj, racw, pfmpj, vMaKS, nYMTR, msm, qyzib, HJFOx, hFdSN, wQL, QupaH, Enn, WjoO, lgDD, eIZa, MwLeVp, NoBYL, IPLlM, MDfuG, tvOHA, EwKNP, HnDP, CFMgKV, DKUAN, bPeBi, pMxDY, dzla, CAKHuW, wmvO, MyeEG, fpqNmT, euGp, rtiem, wVv, kGd, IdaVx, ihqrL, WHCGtv, SUegVX, ZYicGT, UaDC, RcA, byWaAz, GfF, WOEpCN, HKEU, bnLi,
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