SCORE Basic Science 2017-2018
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia
Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using The BARRX™ Anorectal Wand (Clinical Protocol 01-2017) AUGUST 31, 2017 Page 1 of 40 Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia PROTOCOL SIGNATURE PAGE I, , Principal Investigator at site , agree to conduct and follow this protocol: PROTOCOL 01-2017: A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for Anal Intraepithelial Neoplasia using the Barrx™ Anorectal Wand as written according to FDA guidelines. I understand that no deviations from the above protocol may be made without written permission from the Protocol Chair(s). _________________________________ _____________________ Signature Date (mm/dd/yyyy) Page 2 of 40 Protocol 01-2017: RFA for Anal Intraepithelial Neoplasia P ROT O COL S U M M ARY Title A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for Anal Intraepithelial Neoplasia using the Barrx™ Anorectal Wand Design Multi-center prospective trial involving up to 70 subjects Subject Population HIV-positive and HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN) containing at least one high- grade squamous intraepithelial lesions (HSIL) involving the squamocolumnar junction (SCJ). Objective Assess the safety, and efficacy of circumferential radiofrequency ablation (RFA) to the anal canal using the FDA cleared Barrx™ Anorectal Wand to eradicate anal -
Detail Report
Supplemental Update Report CR Number: 2012319113 Implementation Date: 16-Jan-19 Related CR: 2012319113 MedDRA Change Requested Add a new SMQ Final Disposition Final Placement Code # Proposed SMQ Infusion related reactions Rejected After Suspension MSSO The proposal to add a new SMQ Infusion related reactions is not approved after suspension. The ICH Advisory Panel did approve this SMQ topic to go into the development phase and it Comment: underwent testing in three databases (two regulatory authorities and one company). However, there were numerous challenges encountered in testing and the consensus decision of the CIOMS SMQ Implementation Working Group was that the topic could not be developed to go into production as an SMQ. Most notably, in contrast to other SMQs, this query could not be tested using negative control compounds because it was not possible to identify suitable compounds administered via infusion that were not associated with some type of reaction. In addition, there is no internationally agreed definition of an infusion related reaction and the range of potential reactions associated with the large variety of compounds given by infusion is very broad and heterogenous. Testing was conducted on a set of around 500 terms, the majority of which was already included in Anaphylactic reaction (SMQ), Angioedema (SMQ), and Hypersensitivity (SMQ). It proved difficult to identify potential cases of infusion related reactions in post-marketing databases where the temporal relationship of the event to the infusion is typically not available. In clinical trial databases where this information is more easily available, users are encouraged to provide more specificity about the event, e.g., by reporting “Anaphylactic reaction” when it is known that this event is temporally associated with the infusion. -
Hereditary Pancreatitis
Fact Sheet - Hereditary Pancreatitis Hereditary Pancreatitis (HP) is a rare genetic condition characterized by recurrent episodes of pancreatic attacks, which can progress to chronic pancreatitis. Symptoms include abdominal pain, nausea, and vomiting. Onset of attacks typically occurs between within the first two decades of life, but can begin at any age. In the United States, it is estimated that at least 1,000 individuals are affected with hereditary pancreatitis. HP has also been linked to an increased lifetime risk of pancreatic cancer. Pancreatic cancer is the 4th leading cause of cancer deaths among Americans. Individuals with hereditary pancreatitis appear to have a 40% lifetime risk of developing pancreatic cancer. This increased risk is heavily dependent upon the duration of chronic pancreatitis and environmental exposures to alcohol and smoking. One recent study suggested that individuals with chronic pancreatitis for more than 25 years had a higher rate of pancreatic cancer when compared to individuals in the general population. This increased rate appears to be due to the prolonged chronic pancreatitis rather than having a gene mutation (all cationic trypsinogen mutations). It is important to note that these risk values may be higher than expected because these studies on pancreatic cancer use a highly selective population rather than a randomly selected population. At this time, there is no cure for HP. Treating the symptoms associated with HP is the choice method of medical management. Patients may be prescribed pancreatic enzyme supplements to treat maldigestion, insulin to treat diabetes, analgesics and narcotics to control pain, and lifestyle changes to reduce the risk of pancreatic cancer (for example, NO SMOKING!). -
Idiopathic and Hereditary Pancreatitis Testing
Idiopathic and Hereditary Pancreatitis Testing Pancreatitis is a relatively common disorder with multiple etiologies that causes inammation in the pancreas. Acute pancreatitis (AP) is a result of sudden inammation, and patients may present with increased pancreatic enzyme concentrations. Chronic Tests to Consider pancreatitis (CP) is a syndrome of progressive inammation that may lead to permanent damage to pancreatic structure and function. Genetic testing can be utilized to determine Pancreatitis, Panel (CFTR, CTRC, PRSS1, a genetic cause of idiopathic or hereditary AP or CP and/or to assess risk of disease in SPINK1) Sequencing (Temporary Referral as of 12/7/20) 2010876 family members. Method: Polymerase Chain Reaction/Sequencing Preferred test for individuals with history of Disease Overview idiopathic pancreatitis Pancreatitis (CTRC) Sequencing 2010703 Incidence/Prevalence Method: Polymerase Chain Reaction/Sequencing Chronic pancreatitis For adults with idiopathic pancreatitis if other components of panel (CFTR , PRSS1 , SPINK1 ) Incidence: ~4-12/100,000 per year 1 have been sequenced without providing a Prevalence: ~37-42/100,000 1 complete explanation for the pancreatitis Idiopathic chronic pancreatitis is more common than previously thought 2 Pancreatitis (PRSS1) Sequencing and Deletion/Duplication (Temporary Referral Symptoms/Presentation Etiologies as of 01/14/21) 3001768 Method: Polymerase Chain Reaction/Sequencing Acute Sudden onset of pain in Common and Multiplex Ligation Dependent Probe Amplic- pancreatitis the upper abdomen, -
Hereditary Pancreatitis: Outcomes and Risks
HEREDITARY PANCREATITIS: OUTCOMES AND RISKS by Celeste Alexandra Shelton BS, University of Pittsburgh, 2013 Submitted to the Graduate Faculty of the Graduate School of Public Health in partial fulfillment of the requirements for the degree of Master of Science University of Pittsburgh 2015 UNIVERSITY OF PITTSBURGH Graduate School of Public Health This thesis was presented by Celeste Alexandra Shelton It was defended on April 7, 2015 and approved by Thesis Director David C. Whitcomb, MD, PhD, Chief, Division of Gastroenterology, Hepatology and Nutrition, Giant Eagle Foundation Professor of Cancer Genetics, Professor of Medicine, Cell Biology & Physiology and Human Genetics, School of Medicine, University of Pittsburgh Committee Members Randall E. Brand, MD, Professor of Medicine, School of Medicine, University of Pittsburgh, Academic Director, GI-Division, UPMC Shadyside, Dir., GI Malignancy Early Detection, Diagnosis & Prevention Program, Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Robin E. Grubs, PhD, LCGC, Assistant Professor, Director, Genetic Counseling Program, Department of Human Genetics, Graduate School of Public Health, University of Pittsburgh John R. Shaffer, PhD, Assistant Professor, Department of Human Genetics, Graduate School of Public Health, University of Pittsburgh ii Copyright © by Celeste Shelton 2015 iii HEREDITARY PANCREATITIS: OUTCOMES AND RISKS Celeste A. Shelton, MS University of Pittsburgh, 2015 ABSTRACT Pancreatitis is an inflammatory disease of the pancreas that was first identified in the 1600s. Symptoms for pancreatitis include intense abdominal pain, nausea, and malnutrition. Hereditary pancreatitis (HP) is a genetic condition in which recurrent acute attacks can progress to chronic pancreatitis, typically beginning in adolescence. Mutations in the PRSS1 gene cause autosomal dominant HP. -
Infectious Gastroenteritis Generalised Anxiety Disorder HIV Smoking Associated Cancers
BEST PRACTICE 25 DECEMBER 2009 Infectious gastroenteritis Generalised anxiety disorder HIV bpac nz Smoking associated cancers better medicin e Editorial Team Tony Fraser Professor Murray Tilyard We would like to acknowledge the following people for Clinical Advisory Group their guidance and expertise in developing this edition: Michele Cray Dr Shaun Costello, Dunedin Serena Curtis-Lemuelu Dr Edward Coughlan, Christchurch Dr Rosemary Ikram Professor Tony Dowell, Wellington Dr Cam Kyle Dr Rosemary Ikram, Christchurch Dr Chris Leathart Mr William Pearce, Christchurch Dr Lynn McBain Dr Alan Pithie, Christchurch Adam McRae Dr Gabrielle Ruben, Wellington Janet Maloney-Moni Assoc. Professor Mark Thomas, Auckland Dr Peter Moodie Dr Robyn Toomath, Wellington Associate Professor Jim Reid Dr Neil Whittaker, GP Reviewer, Nelson Associate Professor David Reith Assoc. Professor Michael Williams, Dunedin Professor Murray Tilyard Programme Development Team Rachael Clarke Peter Ellison Best Practice Journal (BPJ) Rebecca Harris Julie Knight ISSN 1177-5645 Noni Richards BPJ, Issue 25, December 2009 Dr Tom Swire Dr AnneMarie Tangney nz Dr Sharyn Willis BPJ is published and owned by bpac Ltd Dave Woods Level 8, 10 George Street, Dunedin, New Zealand. Report Development Team Bpacnz Ltd is an independent organisation that promotes health Justine Broadley care interventions which meet patients’ needs and are evidence Todd Gillies based, cost effective and suitable for the New Zealand context. Lana Johnson We develop and distribute evidence based resources which describe, facilitate and help overcome the barriers to best Web practice. Gordon Smith Bpacnz Ltd is currently funded through contracts with PHARMAC Design and DHBNZ. Michael Crawford Bpacnz Ltd has five shareholders: Procare Health, South Link Management and Administration Health, IPAC, the University of Otago and Pegasus Health. -
Prevalence of Pancreatitis in Female and Male Pediatric Patients in Eastern Kentucky in the United States
Central Journal of Family Medicine & Community Health Research Article *Corresponding author Karin N. Westlund, Department of Physiology, University of Kentucky, MS-508 Medical Science Building, 800 Prevalence of Pancreatitis in Rose, Lexington, KY, 40536-0298, USA, Tel: 859-323-0672 or -33668; Email: Submitted: 23 August 2016 Female and Male Pediatric Accepted: 10 November 2016 Published: 12 November 2016 Patients in Eastern Kentucky in ISSN: 2379-0547 Copyright the United States © 2016 Westlund et al. OPEN ACCESS Sabrina L. McIlwrath and Karin N. Westlund* Department of Physiology, University of Kentucky, USA Keywords • Epidemiology • Gender difference Abstract • Recurrent acute pancreatitis Background & aims: Studies in the past decade report worldwide increase of • Tobacco use pediatric pancreatitis. The present study focuses on aUnited States region where the • Obesity first genes associated with hereditary pancreatitis were identified. Aim of the study was to investigate incidences of acute pancreatitis, recurrent acute pancreatitis, and chronic pancreatitis, collecting demographics, etiologies, and comorbid conditions using charted ICD-9-CM codes. Methods: Retrospective chart review was performed on de-identified patient records of hospitalizations at University of Kentucky hospitals between 2005 and 2013. Results: Of 234 children diagnosed during the 9 year time period, 69.2% (n=162) had a single episode of acute, 27.8% (65) recurrent acute, and 16.2% (38) chronic pancreatitis. Surprisingly, the annual incidence for first time diagnosis of acute pancreatitis was significantly higher for female patients (16.1, 95% CI: 13.5- 18.7 per 100,000, P<0.005) compared to males (9.1, 95% CI: 6.8-11.4). Comorbid conditions varied widely depending on patients’ age. -
Pathology of Anal Cancer
Pathology of Anal Cancer a b Paulo M. Hoff, MD, PhD , Renata Coudry, MD, PhD , a, Camila Motta Venchiarutti Moniz, MD * KEYWORDS Anal cancer Anal squamous intraepithelial neoplasia Squamous cell carcinoma Human papilloma virus (HPV) Molecular KEY POINTS Anal cancer is an uncommon tumor, squamous cell carcinoma (SCC) being the most frequent histology corresponding to 80% of all cases. Human papilloma virus (HPV) infection plays a key role in anal cancer development, en- coding at least three oncoproteins with stimulatory properties. SCC expresses CK5/6, CK 13/19, and p63. P16 is a surrogate marker for the presence of HPV genome in tumor cells. INTRODUCTION Anal cancer accounts for approximately 2.4% of gastrointestinal malignancies.1 Although anal cancer is a rare tumor, its frequency is increasing, especially in high- risk groups.2 Tumors in this location are generally classified as anal canal or anal margin. Squamous cell carcinoma (SCC) is the predominant type of tumor and shares many features with cervical cancer. Oncogenic human papilloma virus (HPV) infection plays a major role in both tumors.3 HIV infection is associated with a higher frequency of HPV-associated premalignant lesions and invasive tumors.4 Normal Anatomy of the Anus The anal canal is the terminal part of the large intestine and is slightly longer in male than in female patients. It measures approximately 4 cm and extends from the rectal ampulla (pelvic floor level) to the anal verge, which is defined as the outer open- ing of the gastrointestinal tract. The anal verge is at the level of the squamous- mucocutaneous junction with the perianal skin.5,6 The authors have nothing to disclose. -
HPV, Anal Dysplasia and Anal Cancer
HPV, anal dysplasia FACT and anal cancer SHEET Published 2016 Summary Anal cancer typically develops over a period of years, beginning with a precancerous condition called anal dysplasia. CONTACT US Anal dysplasia occurs when clusters of abnormal cells form by telephone lesions in the mucosa lining of the anal canal (between the 1-800-263-1638 anus and the rectum). The lesions typically form inside the anal 416-203-7122 canal or just outside the anal opening. by fax 416-203-8284 Although there are over 100 different types of the human papillomavirus (HPV), anal dysplasia is usually caused by certain by e-mail strains of HPV which can be transmitted sexually. HPV can shut [email protected] off the proteins that help prevent dysplasia and cancer cells from developing, therefore leading to HPV-associated diseases by mail such as anal dysplasia. 555 Richmond Street West Suite 505, Box 1104 It is difficult to screen for anal dysplasia since the lesions are Toronto ON M5V 3B1 not detectable by routine examinations. As a result, anal dysplasia is often not detected until it has developed into anal cancer, which can be difficult to treat depending on the severity. Specific screening tests can detect dysplasia or precancerous changes. If these precancers are treated, anal cancer may be prevented. Anal cancer is usually treated with radiation and chemotherapy or with surgery. Although anal dysplasia may be treated successfully, individuals with HIV are at increased risk of it recurring and may need to be monitored closely by a trained physician. Consistent condom use reduces, but does not eliminate, the risk of transmitting HPV. -
Genetic Testing for Hereditary Pancreatitis
Genetic Testing for Hereditary Pancreatitis Last Review Date: October 12, 2018 Number: MG.MM.LA.28C3 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence- based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. -
Abdominal Pain
10 Abdominal Pain Adrian Miranda Acute abdominal pain is usually a self-limiting, benign condition that irritation, and lateralizes to one of four quadrants. Because of the is commonly caused by gastroenteritis, constipation, or a viral illness. relative localization of the noxious stimulation to the underlying The challenge is to identify children who require immediate evaluation peritoneum and the more anatomically specific and unilateral inner- for potentially life-threatening conditions. Chronic abdominal pain is vation (peripheral-nonautonomic nerves) of the peritoneum, it is also a common complaint in pediatric practices, as it comprises 2-4% usually easier to identify the precise anatomic location that is produc- of pediatric visits. At least 20% of children seek attention for chronic ing parietal pain (Fig. 10.2). abdominal pain by the age of 15 years. Up to 28% of children complain of abdominal pain at least once per week and only 2% seek medical ACUTE ABDOMINAL PAIN attention. The primary care physician, pediatrician, emergency physi- cian, and surgeon must be able to distinguish serious and potentially The clinician evaluating the child with abdominal pain of acute onset life-threatening diseases from more benign problems (Table 10.1). must decide quickly whether the child has a “surgical abdomen” (a Abdominal pain may be a single acute event (Tables 10.2 and 10.3), a serious medical problem necessitating treatment and admission to the recurring acute problem (as in abdominal migraine), or a chronic hospital) or a process that can be managed on an outpatient basis. problem (Table 10.4). The differential diagnosis is lengthy, differs from Even though surgical diagnoses are fewer than 10% of all causes of that in adults, and varies by age group. -
Incidence of Recurrent High-Grade Anal Dysplasia in HIV-1-Infected Men and Women Following Infrared Coagulation Ablation: a Retrospective Cohort Study
pathogens Article Incidence of Recurrent High-Grade Anal Dysplasia in HIV-1-Infected Men and Women Following Infrared Coagulation Ablation: A Retrospective Cohort Study Javier Corral 1,2,3,*, David Parés 1,2,3, Francesc García-Cuyás 1,2, Boris Revollo 2,4, Ana Chamorro 2,4, Carla Lecumberri 2,5 , Antoni Tarrats 2,5, Eva Castella 6, Marta Piñol 1,2, Bonaventura Clotet 2,3,7, Sebastià Videla 2,8,*,† and Guillem Sirera 2,4,† 1 Department of General Surgery, Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain; [email protected] (D.P.); [email protected] (F.G.-C.); [email protected] (M.P.) 2 Lluita contra la Sida Foundation, Hospital Universitari Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain; brevollo@flsida.org (B.R.); achamorro@flsida.org (A.C.); [email protected] (C.L.); [email protected] (A.T.); [email protected] (B.C.); gsirera@flsida.org (G.S.) 3 School of Medicine, Universitat Autónoma de Barcelona (UAB), Edifici M, Av. de Can Domènech, Bellaterra, 08193 Barcelona, Spain 4 HIV Clinical Unit, Department of Medicine, University Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain 5 Department of Obstetrics and Gynaecology, Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain 6 Department of Pathology, Hospital Germans Trias i Pujol, Carretera de Canyet, s/n, Badalona, Citation: Corral, J.; Parés, D.; 08916 Barcelona, Spain; [email protected] García-Cuyás, F.; Revollo, B.; 7 Retrovirology Laboratory IrsiCaixa Foundation, Carretera de Canyet, s/n, Badalona, 08916 Barcelona, Spain Chamorro, A.; Lecumberri, C.; Tarrats, 8 Department of Clinical Pharmacology, Bellvitge University Hospital/IDIBELL/University of Barcelona, A.; Castella, E.; Piñol, M.; Clotet, B.; Hospitalet de Llobregat, Gran Via de les Corts Catalanes 199–203, 08907 Barcelona, Spain et al.