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Subcutaneous Fat Necrosis

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161. Richard Lehman’s journal review—23 October 2017

, but most of its inflammatory pathways are shared with commoner conditions such as rheumatoid arthritis and the inflammatory bowel diseases. There are actually not that many known pathways, and the summarizes them as: tumour necrosis factor interleukins 12, 17 and 23 Janus kinase pathways. The complexity comes when you get to all the drugs which have been developed to modulate these pathways: inibs and mabs in profusion, typically costing £690/month (tofacitinib) or £704/month (adalimumab). Methotrexate (...) 47) patients who received tofacitinib during the trial.” That seems an awfully high incidence for a trial lasting a few months. Sitting down with a patient who has psoriatic arthritis and a bang up-to-date decision tool, I’d be surprised if she opted to take tofacitinib. JAMA 17 Oct 2017 Vol 318 Oral v subcutaneous semaglutide of semaglutide there was a remarkable 1.9%* lowering of HbA 1c , made even more remarkable by the fact that it was achieved by a peptide travelling through the stomach

2017 The BMJ Blog

162. Pentosan polysulfate sodium (Elmiron) - Interstitial Cystitis

studies (randomized, double-blind, placebo controlled) conducted in Europe which enrolled 115 patients in 7 centres in Denmark and the UK (Holm-Bentzen et al 1987). Another randomized active-controlled study comparing PPS versus Cyclosporine A was conducted in Europe and published in 2005. This study enrolled 64 patients in 7 Finnish urological units (Sairanen et al 2005). A clinical study conducted in Germany included 58 patients in order to evaluate the safety and efficacy of subcutaneous low-dose

2017 European Medicines Agency - EPARs

163. Spherox (spheroids of human autologous matrix-associated chondrocytes) - to repair defects to the cartilage in the knee

Unexpected Serious Adverse Reaction TGF-ß Tumour growth factor TIMP Tissue Inhibitors of Matrix Metalloproteinases TNF Tumour necrosis factor USA or US United States of America VAM Swiss Drug Regulation VAS Visual Analogue Scale WBC White Blood Cell WOMAC-D-Osteoarthritis Index Western Ontario and Mc Master Universities Arthritis Index ZKBS Zentrale Kommission für Biologische Sicherheit, central commission for biological safety ?-GT Gamma glutamyltransferase CHMP assessment report EMA/349863/2017 Page 9

2017 European Medicines Agency - EPARs

164. Obeticholic acid (Ocaliva) - Liver Cirrhosis, Biliary

intrahepatic portosystemic shunt TNF-a tumor necrosis factor-alpha TNF-ß tumor necrosis factor-beta UDCA ursodeoxycholic acid ULN upper limit(s) of normal VAS visual analog scale VLDL very low-density lipoprotein VLDLc very low-density lipoprotein cholesterol WHO World Health Organization WHODDE World Health Organization Drug Dictionary Enhanced Assessment report EMA/725757/2016 Page 7/129 1. Background information on the procedure 1.1. Submission of the dossier The applicant Intercept Italia s.r.l (...) conducted outside the community were carried out in accordance with the ethical standards of Directive 2001/20/EC. • Tabular overview of clinical studies Study No. Objective(s) Bioavailability (BA) Study Reports 747-104 To assess the effect of fed conditions (high fat, high calorie) on the PK of OCA D8601002 To evaluate safety and PK of DSP-1747 (OCA) after single and multiple oral administration of DSP-1747 in Japanese healthy adult male volunteers 747-113 1) Determine the absolute BA of OCA in healthy

2017 European Medicines Agency - EPARs

165. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

administered at a single dose or at repetitive doses was evaluated. Subcutaneous as well as systemic xenograft models were subjected to venetoclax single-agent therapy. The set of toxicology studies was designed to support the development of venetoclax for the target indication based on ICH S9 and for future oncology indications outside of the scope of advanced cancer and falling under the ICH M3 (R2). Conduct of an in vivo micronucleus study, fertility and early embryonic development studies

2017 European Medicines Agency - EPARs

166. Diagnosis and Management of Aplastic Anaemia

(Kelsey, ), even in severe thrombocytopenia. Difficulty obtaining fragments may indicate marrow fibrosis or infiltration and should raise the suspicion of a diagnosis other than AA. In AA, fragments and trails are hypocellular with prominent fat spaces and variable numbers of residual haemopoietic cells. Erythropoiesis is reduced or absent; dyserythropoiesis is very common, often marked and does not distinguish MDS from AA. Megakaryocytes and granulocytic cells are markedly reduced or absent (...) myelofibrosis Primary myelofibrosis is usually accompanied by abnormal blood film (teardrop poikilocytosis, leucoerythroblastic) changes and splenomegaly. The absence of an enlarged spleen in the presence of marrow fibrosis suggests a secondary malignancy Mycobacterial infections Sometimes present with pancytopenia and a hypocellular bone marrow. This is seen more commonly with atypical mycobacteria. Other bone marrow abnormalities include granulomas, fibrosis, marrow necrosis and haemophagocytosis

2015 British Committee for Standards in Haematology

167. Ribociclib (Kisqali) - breast cancer

max 2683 ng/mL, which is in a similar range as the exposure achieved at a dose of 600 mg once daily in humans. When ribociclib was combined with the ER antagonist fulvestrant, at 5 mg/week (subcutaneous injection), the anti-tumour effect was enhanced. The anti-tumour activity of ribociclib was further tested in patient-derived ER+ breast cancer xenograft models (PDX191, HBCx-34) in athymic nude mice. Ribociclib administered at 75 mg/kg/day 6 days/week for 40 days caused significant tumour growth

2017 European Medicines Agency - EPARs

169. Inflammatory Bowel Disease (IBD)

Gastroenterology Organization, 2015 Distal UC Extensive UC CD Quiescent Oral or rectal 5-ASA Oral 5-ASA AZA or 6-MP or MTX Oral AZA or 6-MP Oral AZA or 6-MP Perianal Oral antibiotics AZA or 6-MP I.v. infliximab S.c. adalimumab 5-ASA, 5-aminosalicylic acid; 6-MP, 6-mercaptopurine; AZA, azathioprine; BUD, budesonide; CSA, cyclosporine A; CS, corticosteroid; i.m., intramuscular; i.v., intravenous; MTX, methotrexate; s.c., subcutaneous; TNF, tumor necrosis factor. Note: budesonide only for mild to moderate ileal (...) > ileum ? ICV involved (gaping) ? May appear similar to changes in TB ? TB features less common in intestinal TB (favoring CD): — Longitudinal ulceration — Cobblestoning — Aphthous ulceration — Ileum > cecum — ICV may be stenosed or ulcerated WGO Global Guidelines IBD 18 © World Gastroenterology Organization, 2015 Features TB CD Histopathological ? Large, dense, confluent granulomas ? Submucosal granulomas ? Caseous necrosis and submucosal stenosis ? Caseating changes in intestinal wall and mesenteric

2015 World Gastroenterology Organisation

170. Acute Pain Management: Scientific Evidence

medicine 143 References 144 5. ADMINISTRATION OF ANALGESIC MEDICINES 179 5.1 Oral route 179 5.1.1 Opioids and tramadol 182 5.1.2 Paracetamol 184 5.1.3 Nonselective NSAIDs and coxibs 184 5.2 Intravenous route 185 5.2.1 Opioids and tramadol 185 5.2.2 Paracetamol 186 5.2.3 Nonselective NSAIDs and coxibs 186 5.3 Intramuscular and subcutaneous routes 187 5.3.1 Opioids and tramadol 187 5.3.2 Nonselective NSAIDs and coxibs 188 5.4 Transdermal route 188 5.4.1 Opioids 188 5.4.2 Other medicines 189 5.5 (...) , patient preference and outcomes 241 6.2 Cost of PCA 242 6.3 Medicines used for parenteral PCA 242 6.3.1 Opioids 242 6.3.2 Adjuvant medicines 245 6.4 Program parameters for IV PCA 246 6.4.1 Bolus dose 246 6.4.2 Lockout interval 247 6.4.3 Concurrent background (continuous) infusions 247 6.4.4 Dose limits 247 6.4.5 Loading dose 247 6.5 Efficacy of PCA using other systemic routes of administration 247 6.5.1 Subcutaneous PCA 247 6.5.2 Oral PCA 248 6.5.3 Intranasal PCA 248 6.5.4 Transdermal PCA 248 6.6

2015 Clinical Practice Guidelines Portal

171. 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes

3.2.1. History e352 3.2.2. Physical Examination e352 3.2.3. Electrocardiogram e353 3.2.4. Biomarkers of Myocardial Necrosis e353 3.2.5. Imaging e353 3.3. Prognosis–Early Risk Stratification: Recommendations e353 3.3.1. Rationale for Risk Stratification and Spectrum of Risk: High, Intermediate, and Low e354 3.3.2. Estimation of Level of Risk e354 3.3.2.1. History: Angina Symptoms and Angina Equivalents e354 3.3.2.2. Demographics and History in Diagnosis and Risk Stratification e354 3.3.2.3. Early (...) in patients with true posterior myocardial infarction [MI], Sections 3.3.2.4, 4.3.2, and 7.2.2). NSTE-ACS can be further subdivided on the basis of cardiac biomarkers of necrosis (eg, cardiac troponin, Sections 3.2.4 and 3.4). If cardiac biomarkers are elevated and the clinical context is appropriate, the patient is considered to have NSTEMI ; otherwise, the patient is deemed to have UA. ST depression, transient ST-elevation, and/or prominent T-wave inversions may be present but are not required

2014 American Heart Association

172. Detection and Nonoperative Management of Pediatric Developmental Dysplasia of the Hip in Infants up to Six Months of Age

. Treatment of all forms for DDH has been associated with varying rates of avascular necrosis that represent a possibility of harm to individual patients. Observational and case control studies suggest that the management of children who present with DDH at walking age or older has greater risk of being managed by open surgical hip reduction with its attendant risks of avascular necrosis, infection, hip stiffness, and early onset osteoarthritis as an adult I-1, I-4, I-8, I-9, I-18, I-30, I-31 . The harms

2014 American Academy of Orthopaedic Surgeons

173. Management of Obesity and Overweight

of Life 108 Appendix F: Motivational Interviewing 110 Evidence for Effectiveness of Motivational Interviewing 110 Motivational Interviewing Approaches and Strategies 111 Learning Motivational Interviewing 112 Appendix G: Comprehensive Lifestyle Intervention and Behavioral Approaches 113 Specific Behavioral Strategies Featured in Comprehensive Lifestyle Interventions 114 Appendix H: Dietary Elements 117 Low-Calorie Diets 117 Very-Low-Calorie Diets 118 Low-Fat Diets 119 Low-Carbohydrate Diets 120 Low

2014 VA/DoD Clinical Practice Guidelines

174. Type 1 Diabetes Mellitus and Cardiovascular Disease: A Scientific Statement From the American Heart Association and American Diabetes Association

prominence in women are not clear, but the reported data suggest sex differences in CAC in patients with T1DM are explained by fat distribution patterns associated with insulin resistance (waist-to-hip ratio, waist circumference). , , Another hypothesis is that lower levels of high-density lipoprotein cholesterol (HDL-C) explain the equalization of CAC between the sexes. Overall, T1DM appears to eliminate most of the female sex protection seen in the nondiabetic population. Race/Ethnicity Little is known (...) disease duration of 2 years, independent of adiposity and glycemia. Other inflammatory markers such as soluble interleukin-2 receptor and CD40 ligand , are higher in patients with T1DM than in nondiabetic subjects. Inflammation is evident in youth, even soon after the diagnosis of T1DM. Intensive treatment has been linked to decreases in soluble intercellular adhesion molecule type 1 and increases in soluble tumor necrosis factor-α receptor 1 in the DCCT. Some data link inflammation in T1DM to CVD

2014 American Heart Association

176. The use of bisphosphonates in children - review of the literature guidelines for dental management

). 24,25 Hypercalcaemia secondary to disorders such as malignancy, William syndrome and subcutaneous fat necrosis have been treated successfully with 1 to 2 doses of intravenous bisphosphonate; 26–28 and they have also proven bene- ?cial in delayed bone healing. 29 The bisphosphonate treatment regimen and dura- tion of treatment is variable and dependent on the diagnosis and response to therapy. Pamidronate tends to be administered at a dose of 9 mg/kg/year, given at intervals of between 1 to 4 monthly (...) and osteo- blastic lesions induced by 13-Cis-retinoic acid mimicking relapsed neuroblastoma. Pediatr Blood Cancer 2009;53:666– 668. 27. Sangun O, Dundar BN, Erdogan E. Severe hypercalcemia asso- ciated with Williams syndrome successfully treated with pamidronate infusion therapy. J Pediatr Endocrinol Metab 2011;24:69–70. 28. Alos N, Eugene D, Fillion M, Powell J, Kokta V, Chabot G. Pamidronate: treatment for severe hypercalcemia in neonatal subcutaneous fat necrosis. Horm Res 2006;65:289–294. 29. Birke

2014 Clinical Practice Guidelines Portal

177. Xalkori (crizotinib)

, respectively. ? variant 1: fusion protein consisting of EML4 exon 13 and ALK exon 20 ? variant 2: fusion protein consisting of EML4 exon 20 and ALK exon 20 ? variant 3a: fusion protein consisting of EML4 exon 6 and ALK exon 20 ? variant 3b: fusion protein consisting of EML4 exon 6 and ALK exon 20, with 10 more amino acid residues than variant 3a ? variant 3: variant 3a and variant 3b In vivo: The effect of crizotinib to inhibit tumor growth was evaluated using athymic mice (nude mice) subcutaneously (...) – (increase in tumor volume from Day 13 to 26 after implantation in each dose group / increase in tumor volume from Day 13 to 26 after implantation in the control group)] × 100) NCI-H3122 cell line was subcutaneously implanted in nude mice. Starting on the day when the tumor volume reached the pre-specified size, crizotinib (50, 100, 200 mg/kg) was administered orally QD to the animals for 4 consecutive days. Apoptosis induction in the tumor mass at 7 hours after the last dose of crizotinib was evaluated

2012 Pharmaceuticals and Medical Devices Agency, Japan

178. Treatment and prevention of Mycobacterium ulcerans infection (Buruli ulcer) in Australia - a guideline update

or liquefied subcutaneous fat. When antibiotics are not tolerated, contraindicated or declined, curative excisional surgery can be attempted without antibiotics, or with a shorter duration of antibiotics in cases of intolerance. The excision should be performed with wide margins through uninvolved tissue. However, there is a risk of disease relapse, either locally or distantly, which is greater if histological margins of the excised specimen include visible bacteria or active inflammation, the patient (...) destructive infection of skin and of adipose and soft tissue caused by Mycobacterium ulcerans , an environmental pathogen that produces a potent toxin. It is because of progressive destruction of subcutaneous tissue that the characteristic ulcer becomes widely undermined. BU only occurs in specific endemic areas, particularly coastal Victoria, where the disease is known locally as Bairnsdale ulcer. The second major Australian focus is a small region between Mossman and just beyond the Daintree River

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2014 Clinical Practice Guidelines Portal

180. Metabolic syndrome and extensive adipose tissue inflammation in morbidly obese Göttingen minipigs (PubMed)

, but not subcutaneous, adipose tissue of DIO-GM.The Munich DIO-GM model resembles hallmarks of the human metabolic syndrome with extensive adipose tissue inflammation and adipocyte necrosis reported for the first time. DIO-GM may be used for evaluating novel treatments of obesity and associated comorbidities. They may help to identify triggers and mechanisms of fat tissue inflammation and mechanisms preventing complete metabolic decompensation despite morbid obesity.Copyright © 2018 The Authors. Published (...) ). Body composition, blood parameters and intravenous glucose tolerance were determined at regular intervals. A pilot chronic treatment trial with a GLP1 receptor agonist was conducted in DIO-GM. At the end of the study, the animals were necropsied and a biobank of selected tissues was established.DIO-GM developed severe subcutaneous and visceral adiposity (body fat >50% of body mass vs. 22% in L-GM), increased plasma cholesterol, triglyceride, and free fatty acid levels, insulin resistance (HOMA-IR

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2018 Molecular metabolism

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