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Subcutaneous Fat Necrosis

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181. Padeliporfin (Tookad) - prostate cancer / Prostatic Neoplasms

parameter CRF case report form CSR Clinical Study Report CTCAE Common Terminology Criteria for Adverse Events CTGC Central Treatment Guidance Committee DRE digital rectal examination DSMB Data Safety Monitoring Board EC European Commission ECG electrocardiogram EMA European Medicines Agency EPN Extra-prostatic necrosis EQ-5D EuroQol-5D 5-ARI 5-a-reductase inhibitor EU European Union GC Gas Chromatography GCP Good Clinical Practice GLP Good Laboratory Practice GMP Good manufacturing practice HPLC High (...) with a light dose of 200 J/cm is efficient in inducing necrosis in the dog prostate. In addition, no major secondary effects, changes in heart rate, oximetry, or body temperature have been observed thus far. No evidence of thrombosis in other organs (lung, pulmonary artery, and liver tissues) has been observed, confirming that the VTP effect is localized to the prostate. The results of studies in other tissues such as biliary, lung and renal tissue did not reveal toxicity on haemodynamic parameters (data

2017 European Medicines Agency - EPARs

182. 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

183. 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

184. 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

185. 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

186. 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

187. Paediatric Urology

also be a cause of acute scrotum as it can relate to post traumatic haematomas, testicular contussion, rupture dislocation or torsion [88-93]. Scrotal fat necrosis has also been reported to be an uncommon cause of mild-to-moderate scrotal pain in prepubertal overweight boys after exposure to cold [94]. Torsion of the testis occurs most often in the neonatal period and around puberty, whereas torsion of the appendix testes occurs over a wider age range. Acute epididymitis affects two age groups: 360 (...) ring and brings a risk of preputial necrosis. 3A.3 Diagnostic evaluation The diagnosis of phimosis and paraphimosis is made by physical examination. If the prepuce is not retractable or only partly retractable and shows a constrictive ring on drawing back over the glans penis, a disproportion between the width of the foreskin and the diameter of the glans penis has to be assumed. In addition to the constricted foreskin, there may be adhesions between the inner surface of the prepuce

2015 European Association of Urology

188. Renal Cell Carcinoma

) and chromophobe (chRCC). RCC type classification has been confirmed by cytogenetic and genetic analyses [27-29] (LE: 2b). Collecting duct carcinoma and other infrequent renal tumours are discussed in Section 3.3. Histological diagnosis includes, besides RCC type, evaluation of nuclear grade, sarcomatoid features, vascular invasion, tumour necrosis, and invasion of the collecting system and perirenal fat. Fuhrman nuclear grade has been the most widely accepted grading system [30]. At the ISUP conference (...) , a simplified, nuclear grading system, based only on size and shape of nucleoli, has been proposed which will replace the Fuhrman grading system [5]. 3.2.1 Clear cell (ccRCC) Grossly, ccRCC is well circumscribed, capsule is usually absent. The cut surface is golden-yellow, often with haemorrhage and necrosis. The Fuhrman nuclear grading system is generally used [30]. Loss of chromosome 3p and mutation of the VHL (von Hippel-Lindau) gene at chromosome 3p25 are frequently found. ccRCC has a worse prognosis

2015 European Association of Urology

190. 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 History: Angina Symptoms and Angina Equivalents e354 Demographics and History in Diagnosis and Risk Stratification e354 Early (...) in patients with true posterior myocardial infarction [MI], Sections, 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

191. 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

192. 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

193. 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

195. 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

196. 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

199. 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

200. Anoplasty for Post-hemorrhoidectomy Low Anal Stenosis: A New Technique. (PubMed)

patients treated over a period of 20 years. The data were prospectively recorded by the author. The essence of this simple procedure is mobilizing the anal mucosa to the dentate line via a vertical incision and mobilizing the adjacent perianal skin and subcutaneous fat to allow a completely tension-free approximation of the perianal skin and the anal mucosa which are sutured together transversely. A tension-releasing incision is made in the perianal region which is left to heal by secondary (...) Anoplasty for Post-hemorrhoidectomy Low Anal Stenosis: A New Technique. Post-hemorrhoidectomy anal stenosis though rare is very disturbing and devastating complication. Many surgical procedures have been described, but despite good results, many complications can ensue like flap necrosis, mucosal ectropion, and restenosis.We report a new simple technique for repair of severe/moderate anal stenosis which requires no extensive flap mobilization or many sutures.This is a personal series of 65

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2018 World Journal of Surgery

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