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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 -
Use of Inflated Foley Catheters to Prevent Early Empty Pelvis Complications Following Pelvic Exenteration
ANTICANCER RESEARCH 35: 5543-5546 (2015) Use of Inflated Foley Catheters to Prevent Early Empty Pelvis Complications Following Pelvic Exenteration NICOLAE BACALBASA1, DANA TOMESCU2 and IRINA BALESCU3 1Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; 2Fundeni Clinical Institute, Department of Anaethesia and Critical Care III, Bucharest, Romania; 3Ponderas Hospital, Bucharest, Romania Abstract. For most patients with bulky pelvic tumors, neoadjuvant chemo-irradiation is performed in order to pelvic exenteration remains the only curative option. diminish the local invasion and to transform the patient into Although initially reported as a palliative procedure, a candidate for a less extended resection. However, there nowadays it is rather performed with curative intent. Once are cases in which local invasion persists after neoadjuvant the resectional phase is ended, a large defect will remain at treatment and in which pelvic exenteration is needed. Since the level of the pelvic diaphragm, predisposing to severe Brunschwig reported it for the first time in 1948, this complications which are generically included under the surgical procedure has become the golden-standard for name of empty pelvis syndrome. It has been widely patients with locally invasive pelvic malignancies (3). demonstrated that this type of complication is associated Although the resectional phase has remained practically with severe mortality, even if the patient is free of any pelvic unchanged, the reconstructive phase has undergone multiple recurrence. We present the case of a 56-year-old patient improvements in order to improve the patient quality of submitted to total pelvic exenteration for locally invasive life. However, there are still cases in which a reconstruction previously chemo-irradiated cervical cancer who presented is not possible at the time of resection; in all such cases, a six months after surgery with a severe enteroperineal fistula. -
Benign Tumors and Tumor-Like Lesions of the Vulva
Please do not remove this page Benign Tumors and Tumor-like Lesions of the Vulva Heller, Debra https://scholarship.libraries.rutgers.edu/discovery/delivery/01RUT_INST:ResearchRepository/12643402930004646?l#13643525330004646 Heller, D. (2015). Benign Tumors and Tumor-like Lesions of the Vulva. In Clinical Obstetrics & Gynecology (Vol. 58, Issue 3, pp. 526–535). Rutgers University. https://doi.org/10.7282/T3RN3B2N This work is protected by copyright. You are free to use this resource, with proper attribution, for research and educational purposes. Other uses, such as reproduction or publication, may require the permission of the copyright holder. Downloaded On 2021/09/23 14:56:57 -0400 Heller DS Benign Tumors and Tumor-like lesions of the Vulva Debra S. Heller, MD From the Department of Pathology & Laboratory Medicine, Rutgers-New Jersey Medical School, Newark, NJ Address Correspondence to: Debra S. Heller, MD Dept of Pathology-UH/E158 Rutgers-New Jersey Medical School 185 South Orange Ave Newark, NJ, 07103 Tel 973-972-0751 Fax 973-972-5724 [email protected] Funding: None Disclosures: None 1 Heller DS Abstract: A variety of mass lesions may affect the vulva. These may be non-neoplastic, or represent benign or malignant neoplasms. A review of benign mass lesions and neoplasms of the vulva is presented. Key words: Vulvar neoplasms, vulvar diseases, vulva 2 Heller DS Introduction: A variety of mass lesions may affect the vulva. These may be non-neoplastic, or represent benign or malignant neoplasms. Often an excision is required for both diagnosis and therapy. A review of the more commonly encountered non-neoplastic mass lesions and benign neoplasms of the vulva is presented. -
COVID-19 Mrna Pfizer- Biontech Vaccine Analysis Print
COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print All UK spontaneous reports received between 9/12/20 and 22/09/21 for mRNA Pfizer/BioNTech vaccine. A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines. All reports are kept under continual review in order to identify possible new risks. Report Run Date: 24-Sep-2021, Page 1 Case Series Drug Analysis Print Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print Report Run Date: 24-Sep-2021 Data Lock Date: 22-Sep-2021 18:30:09 MedDRA Version: MedDRA 24.0 Reaction Name Total Fatal Blood disorders Anaemia deficiencies Anaemia folate deficiency 1 0 Anaemia vitamin B12 deficiency 2 0 Deficiency anaemia 1 0 Iron deficiency anaemia 6 0 Anaemias NEC Anaemia 97 0 Anaemia macrocytic 1 0 Anaemia megaloblastic 1 0 Autoimmune anaemia 2 0 Blood loss anaemia 1 0 Microcytic anaemia 1 0 Anaemias haemolytic NEC Coombs negative haemolytic anaemia 1 0 Haemolytic anaemia 6 0 Anaemias haemolytic immune Autoimmune haemolytic anaemia 9 0 Anaemias haemolytic mechanical factor Microangiopathic haemolytic anaemia 1 0 Bleeding tendencies Haemorrhagic diathesis 1 0 Increased tendency to bruise 35 0 Spontaneous haematoma 2 0 Coagulation factor deficiencies Acquired haemophilia -
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. -
Surgical Excision of Eyelid Lesions Reference Number: CP.VP.75 Coding Implications Last Review Date: 12/2020 Revision Log
Clinical Policy: Surgical Excision of Eyelid Lesions Reference Number: CP.VP.75 Coding Implications Last Review Date: 12/2020 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description: The majority of eyelid lesions are benign, ranging from innocuous cysts and chalazion/hordeolum to nevi and papillomas. Key features that should prompt further investigation include gradual enlargement, central ulceration or induration, irregular borders, eyelid margin destruction or loss of lashes, and telangiectasia. This policy describes the medical necessity requirements for surgical excision of eyelid lesions. Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® (Centene) that surgical excision and repair of eyelid or conjunctiva due to lesion or cyst or eyelid foreign body removal is medically necessary for any of the following indications: A. Lesion with one or more of the following characteristics: 1. Bleeding; 2. Persistent or intense itching; 3. Pain; 4. Inflammation; 5. Restricts vision or eyelid function; 6. Misdirects eyelashes or eyelid; 7. Displaces lacrimal puncta or interferes with tear flow; 8. Touches globe; 9. Unknown etiology with potential for malignancy; B. Lesions classified as one of the following: 1. Malignant; 2. Benign; 3. Cutaneous papilloma; 4. Cysts; 5. Embedded foreign bodies; C. Periocular warts associated with chronic conjunctivitis. Background The majority of eyelid lesions are benign, ranging from innocuous cysts and chalazion/hordeolum to nevi and papillomas. Key features that should prompt further investigation include gradual enlargement, central ulceration or induration, irregular borders, eyelid margin destruction or loss of lashes, and telangiectasia. Benign tumors, even though benign, often require removal and therefore must be examined carefully and the differential diagnosis of a malignant eyelid tumor considered and the method of removal planned. -
Faculty Meeting August 9Th, 2011
Review of Systems is a process that includes a review of body systems. It is carried out through a series of questions regarding signs and symptoms. The Review of Systems (ROS) includes information about the following 14 systems. Constitutional: description of general appearance; growth and development, recent weight loss/gain, malaise, chills weakness, fatigue, fever, vital signs, head circumference for a baby, appetite, sleep habits, insomnia, night sweats. Integumentary: (skin and/or breast) rashes, color, sores, dryness, itching, flaking, dandruff, lumps, moles, color change, changes in hair or nails, sweating, hives, bruising, scratches, scars, swelling., acne. Eyes: vision, no change in vision, glasses or contact lenses, last eye exam, eye pain, “eye” redness, excessive tearing, double vision, blurred vision, spots, specks, flashing lights, photophobia, glaucoma, cataracts. Ears, Nose, Mouth/ Throat Ears: hearing loss, tinnitus, vertigo, earaches, ear infections, ear discharges; if hearing is decreased, use of hearing aids. Nose and sinuses: frequent colds, stuffiness’, discharge drainage, nasal itching, hay fever, nosebleeds sinusitis, sinus trouble, sinus pressure, nasal congestion, nasal discharge, nasal infection Mouth/Throat condition of teeth and gums bleeding gums dentures, (how they fit) last dental exam, dry mouth, frequent sore throats, difficulty swallowing, no posterior pharynx pain, hoarseness, sores/ulcers, hoarseness, pyorrhea. Respiratory: cough, sputum, (color, quantity) shortness of breath, pleuritic chest pain, wheezing, asthma, bronchitis, TB, emphysema, pneumonia, hemoptysis, CXR. Cardiovascular: heart trouble; high blood pressure; CV hypertension, heart murmurs, chest pain/ pressure palpitations, dyspnea, orthopnea,, rheumatic fever, paroxysmal nocturnal dyspnea, edema; past EKG or other heart tests. Peripheral Vascular; intermittent claudication, leg cramps, varicose veins, past clots in the vein, syncope, edema. -
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. -
Recognizing Common and Uncommon Birthmarks Harper N
Doctor should I be worried? Recognizing common and uncommon birthmarks Harper N. Price, MD, FAAD, FAAP Division Chief, Fellowship Director Friday, June 28, 10:50-11:35am Conflicts of interest: • None Learning objectives • Recognize common and less common congenital skin lesions in the outpatient setting • RED Vascular lesions: capillary malformations, hemangiomas, vascular tumors • BROWN Pigmented lesions: congenital nevi • BLUE dermal melanoyctosis • YELLOW/TAN Benign hamartomas: nevus sebaceous, connective tissue nevi • Developmental anomalies: aplasia cutis, hair collar sign • Identify those congenital skin lesions that require urgent referral and additional investigations Red birthmarks Classification of vascular anomalies • Incorrect nomenclature misunderstanding between colleagues and with patients • Incorrect nomenclature misdiagnosis • Accurate diagnosis is crucial for appropriate evaluation and management • Classification serves as a guide for clinicians Archaic terms • “Strawberry hemangioma” • “Cavernous hemangioma” • “Capillary hemangioma” • Historically speaking “hemangioma” has been used for vascular tumors and malformations Wassef M et al. Pediatr 2015 A simpler version Puttgen KB. Pediatr Clin N Am. 2014 Infantile hemangiomas (IH): classic vascular “tumor” • 4-10% of infants, head and neck • Most common soft tissue tumor of infancy • Present first few weeks of life • Proliferation of benign endothelial cells • Initial rapid growth followed by slow involution Infantile hemangiomas: risk factors • Low birth weight infants -
2016 Essentials of Dermatopathology Slide Library Handout Book
2016 Essentials of Dermatopathology Slide Library Handout Book April 8-10, 2016 JW Marriott Houston Downtown Houston, TX USA CASE #01 -- SLIDE #01 Diagnosis: Nodular fasciitis Case Summary: 12 year old male with a rapidly growing temple mass. Present for 4 weeks. Nodular fasciitis is a self-limited pseudosarcomatous proliferation that may cause clinical alarm due to its rapid growth. It is most common in young adults but occurs across a wide age range. This lesion is typically 3-5 cm and composed of bland fibroblasts and myofibroblasts without significant cytologic atypia arranged in a loose storiform pattern with areas of extravasated red blood cells. Mitoses may be numerous, but atypical mitotic figures are absent. Nodular fasciitis is a benign process, and recurrence is very rare (1%). Recent work has shown that the MYH9-USP6 gene fusion is present in approximately 90% of cases, and molecular techniques to show USP6 gene rearrangement may be a helpful ancillary tool in difficult cases or on small biopsy samples. Weiss SW, Goldblum JR. Enzinger and Weiss’s Soft Tissue Tumors, 5th edition. Mosby Elsevier. 2008. Erickson-Johnson MR, Chou MM, Evers BR, Roth CW, Seys AR, Jin L, Ye Y, Lau AW, Wang X, Oliveira AM. Nodular fasciitis: a novel model of transient neoplasia induced by MYH9-USP6 gene fusion. Lab Invest. 2011 Oct;91(10):1427-33. Amary MF, Ye H, Berisha F, Tirabosco R, Presneau N, Flanagan AM. Detection of USP6 gene rearrangement in nodular fasciitis: an important diagnostic tool. Virchows Arch. 2013 Jul;463(1):97-8. CONTRIBUTED BY KAREN FRITCHIE, MD 1 CASE #02 -- SLIDE #02 Diagnosis: Cellular fibrous histiocytoma Case Summary: 12 year old female with wrist mass. -
Genetic Heterogeneity Intuberous Sclerosis: Phenotypic Correlations
J Med Genet: first published as 10.1136/jmg.27.7.418 on 1 July 1990. Downloaded from 4184 Med Genet 1990; 27: 418-421 Genetic heterogeneity in tuberous sclerosis: phenotypic correlations I M Winship, J M Connor, P H Beighton Abstract sistently present in families in whom the gene for There is increasing evidence for genetic hetero- TSC is not on 9q34. We conclude that confetti geneity in tuberous sclerosis (TSC) on the basis of depigmentation and nuchal skin tags may be clinical linkage analysis in affected kindreds. We have per- pointers to an alternative locus for TSC. formed a detailed assessment of an affected South African family in which there is no evidence of linkage to chromosome 9 markers. The affected persons have atypical clinical features, namely Tuberous sclerosis (TSC) is inherited as an autosomal prominent nuchal skin tags, a confetti pattern of dominant trait and is characterised by multisystem hypopigmentation of the skin of the lower legs, and hamartosis. The areas of predilection are the skin, absence of ungual fibromata. Further investigation central nervous system, kidneys, and heart, while of these unusual phenotypic features is warranted in other organs are less frequently affected.' Certain skin order to determine whether these lesions are con- lesions are pathognomonic of TSC (adenoma seba- ceum, periungual fibromata, shagreen patches, fibrous facial plaques). Other skin changes may be copyright. MRC Unit for Inherited Skeletal Disorders, Department suggestive (ash leaf macules) or compatible with the of Human Genetics, University of Cape Town Medical diagnosis of TSC in the appropriate clinical setting School, Observatory 7925, South Africa.