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Medication Causes of Dyspepsia

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141. Impact of morphine, fentanyl, oxycodone or codeine on patient consciousness, appetite and thirst when used to treat cancer pain. (PubMed)

Impact of morphine, fentanyl, oxycodone or codeine on patient consciousness, appetite and thirst when used to treat cancer pain. There is increasing focus on providing high quality care for people at the end of life, irrespective of disease or cause, and in all settings. In the last ten years the use of care pathways to aid those treating patients at the end of life has become common worldwide. The use of the Liverpool Care Pathway in the UK has been criticised. In England the LCP (...) journal publication articles.Two review authors independently extracted adverse event data, and examined issues of study quality. The primary outcomes sought were numbers of participants experiencing adverse events of reduced consciousness, appetite, and thirst. Secondary outcomes were possible surrogate measures of the primary outcomes: delirium, dizziness, hallucinations, mood change and somnolence relating to patient consciousness, and nausea, vomiting, constipation, diarrhoea, dyspepsia, dysphagia

2014 Cochrane

142. Sofosbuvir/velpatasvir/voxilaprevir (chronic hepatitis C) - Addendum to Commission A17-35

ACT appropriate comparator therapy AE adverse event CHC chronic hepatitis C CI confidence interval DAA direct acting antiviral agent G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) MedDRA Medical Dictionary for Regulatory Activities NS5A non-structural protein 5A PT Preferred Term RCT randomized controlled trial RR relative risk SAE serious adverse event SOC (...) study nor for the POLARIS-4 study presented as additional information. The reason was that the company had not presented the analyses of all AEs by System Organ Class (SOC) and Preferred Terms (PTs) according to the Medical Dictionary for Regulatory Activities (MedDRA) for the corresponding subpopulations. With its comments, the company subsequently submitted corresponding analyses at SOC and PT level for AEs and serious AEs (SAEs). Concurring with the methods described in the dossier assessment [1

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

143. Milk Thistle (PDQ®): Health Professional Version

thistle or silymarin primarily in individuals with or , although small studies have been reported about individuals with , , , , and . Few adverse have been reported for milk thistle, but little information about interactions with anticancer medications, , or other drugs is available. Milk thistle is available in the United States as a . Many of the medical and scientific terms used in this summary are hypertext linked (at first use in each section) to the , which is oriented toward nonexperts. When (...) in the specified amounts. The FDA has not approved the use of milk thistle as a treatment for patients or patients with any other medical condition. Despite milk thistle’s long history of being used to treat and complaints, it was not until 1968 that silymarin was isolated from the seeds of the plant, and it was proposed that silymarin might be the active ingredient.[ ] Researchers have investigated the role that silibinin may play in the treatment of and . Most studies have investigated the isolated compound

2018 PDQ - NCI's Comprehensive Cancer Database

144. Cartilage (Bovine and Shark) (PDQ®): Health Professional Version

is no longer being updated and is provided for reference purposes only. This information summary provides an overview of the use of as a treatment for people with cancer. The summary includes a brief history of cartilage research, the results of , and possible of cartilage use. This summary contains the following key information: Bovine (cow) cartilage and shark cartilage have been studied as treatments for people with cancer and other medical conditions for more than 30 years. Numerous cartilage products (...) , and the results are inconclusive. Additional of cartilage as a treatment for people with cancer are now being conducted. Many of the medical and scientific terms used in this summary are hypertext linked (at first use in each section) to the , which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window. Reference citations in some cancer information summaries may include links to external websites that are operated by individuals or organizations

2018 PDQ - NCI's Comprehensive Cancer Database

145. Autosomal Dominant Polycystic Kidney Disease - Management of Polycystic Liver Disease

,some,mainlythose with severe cystic liver disease, have abdominal pain or swelling, and, less commonly, dyspepsia, early satiety, dyspnea, and back pain. The severity of cystic liver disease can be assessed by magnetic resonance imaging (MRI), based on total cyst number or total liver volume. 5 Complications such as hepatic cyst infection and bleeding cause pain acutely, and are not uncommon, occurring in at least 5% of patients. 7 The treatment is the same as for infected or bleeding kidney cysts (...) LSD symposium; and Gopala Rangan is a member of the advisory committee on the Safety of Medical Devices and received ?nancial support to attend the KDIGO Controversies on Autosomal Dominant Polycystic Kidney Disease meeting in 2014. * The University of Melbourne, Department of Medicine, Melbourne Health and Northern Health, Melbourne, Australia. † Department of Nephrology, The Royal Melbourne Hospital, Park- ville, Victoria, Australia. ‡ Kidney Health Service and Conjoint Kidney Research

2015 KHA-CARI Guidelines

146. Atrial Fibrillation ? Diagnosis and Management

benefit status for medication coverage and specific medical circumstances of coverage depending on BC PharmaCare plan rules. Diagnostic code: 427.3, I48 2 BCGuidelines.ca: Use of Non-Vitamin K Antagonist Oral Anticoagulants (NOAC) in Non-Valvular Atrial Fibrillation: Appendix A (2015)BCGuidelines.ca: Atrial Fibrillation – Diagnosis and Management (2015) 11 Appendices • Appendix A: Types of Atrial Fibrillation • Appendix B: Possible Causes of Atrial Fibrillation • Appendix C: Assessing Atrial (...) approach to the management of clinical problem. We cannot respond to patients or patient advocates requesting advice on issues related to medical conditions. If you need medical advice, please contact a health care professional.Appendix A: Types of Atrial Fibrillation 1,2 Abnormalities or damage to the heart’s structure are the most common cause of atrial fibrillation (AF). Note these types are not exclusive of each other. Valvular AF Occurs in the presence of rheumatic mitral stenosis, a mechanical

2015 Clinical Practice Guidelines and Protocols in British Columbia

147. Breast Cancer Treatment (PDQ®): Health Professional Version

factors for ductal and lobular breast cancer: results from the nurses' health study. Breast Cancer Res 12 (6): R106, 2010. [ ] [ ] Goldacre MJ, Abisgold JD, Yeates DG, et al.: Benign breast disease and subsequent breast cancer: English record linkage studies. J Public Health (Oxf) 32 (4): 565-71, 2010. [ ] [ ] Kabat GC, Jones JG, Olson N, et al.: A multi-center prospective cohort study of benign breast disease and risk of subsequent breast cancer. Cancer Causes Control 21 (6): 821-8, 2010

2018 PDQ - NCI's Comprehensive Cancer Database

148. Proton Pump Inhibitors for Gastrointestinal Conditions

to 6.8 million person, with incidence of 170,000 per year among adults, and 56,000 in the pediatric population. 5 Besides the gastrointestinal/abdominal symptoms, GERD has also been associated with extra-esophageal symptoms such as cough, hoarseness, laryngeal problems, ear disease, and dental erosion. 4,6 Gastroesophageal reflux disease (GERD) symptoms and sequelae are associated with reduced quality of life, causing considerable morbidity which contribute to substantial medication use and economic (...) with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

149. Pertuzumab (Perjeta or Perjeta-Herceptin Combo Pack) for Neoadjuvant Breast Cancer

, they are made available for informational and educational purposes only. This report should not be used as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision making process, or as a substitute for professional medical advice. Liability pCODR does not assume any legal liability or responsibility for the accuracy, completeness or usefulness of any information, drugs, therapies, treatments, products, processes (...) , or services disclosed. The information is provided "as is" and you are urged to verify it for yourself and consult with medical experts before you rely on it. You shall not hold pCODR responsible for how you use any information provided in this report. Reports generated by pCODR are composed of interpretation, analysis, and opinion on the basis of information provided by pharmaceutical manufacturers, tumour groups, and other sources. pCODR is not responsible for the use of such interpretation, analysis

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

150. Stool Antigen Tests for Helicobacter pylori Infection

Stool Antigen Tests for Helicobacter pylori Infection TITLE: Stool Antigen Tests for Helicobacter pylori Infection: A Review of Clinical and Cost-Effectiveness and Guidelines DATE: 08 January 2015 CONTEXT AND POLICY ISSUES Helicobacter pylori (H. pylori) is Gram negative bacillus that colonizes the mucus layer of the human stomach and the upper part of small intestine (duodenum). 1,2 It is the principal cause of peptic ulcer disease and the main risk of gastric cancer. 2 Most infected (...) in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

151. Evidence Map of Acupuncture

Evidence Map of Acupuncture Evidence-based Synthesis Program Department of Veterans Affairs Health Services Research & Development Service January 2014 Prepared for: Department of Veterans Affairs Veterans Health Administration Quality Enhancement Research Initiative Health Services Research & Development Service Washington, DC 20420 Prepared by: Evidence-based Synthesis Program (ESP) Center West Los Angeles VA Medical Center Los Angeles, CA Paul G. Shekelle, MD, PhD, Director Investigators (...) citation: Hempel, S., Taylor, S. L., Solloway, M., Miake-Lye, I. M., Beroes, J. M., Shanman, R., Booth, M. J., Siroka, A. M., Shekelle, P. G. Evidence Map of Acupuncture. VA- ESP Project #05-226; 2013 This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Center located at the West Los Angeles VA Medical Center, Los Angeles, CA funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research

2014 Veterans Affairs Evidence-based Synthesis Program Reports

152. Aspirin for prophylactic use in the primary prevention of cardiovascular disease and cancer: a systematic review and overview of reviews

for prophylactic use in the primary prevention of cardiovascular disease and cancer: a systematic review and overview of reviews P Sutcliffe, M Connock, T Gurung, K Freeman, S Johnson, N-B Kandala, A Grove, B Gurung, S Morrow and A Clarke* Warwick Evidence, Warwick Medical School, University of Warwick, Coventry, UK * Corresponding author Declared competing interests of authors: none Published September 2013 DOI: 10.3310/hta17430 This report should be referenced as follows: Sutcliffe P, Connock M, Gurung T (...) Journals Library (www.journalslibrary.nihr.ac.uk), produced by Prepress Projects Ltd, Perth, Scotland (www.prepress-projects.co.uk).Editor-in-Chief of Health Technology Assessment and NIHR Journals Library Professor Tom Walley Director, NIHR Evaluation, Trials and Studies and Director of the HTA Programme, UK NIHR Journals Library Editors Professor Ken Stein Chair of HTA Editorial Board and Professor of Public Health, University of Exeter Medical School, UK Professor Andree Le May Chair of NIHR

2013 NIHR HTA programme

153. Semaglutide (Ozempic) - Diabetes Mellitus

9 2.1.2. Epidemiology and risk factors 10 2.1.3. Biologic features 10 2.1.4. Available therapies and unmet medical need 10 2.1.5. About the product 11 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active Substance 12 2.2.3. Finished Medicinal Product 15 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 18 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 19 2.2.6. Recommendation for future quality development 20 2.3. Non-clinical aspects 20 (...) interactions and other interactions 127 Discontinuation due to AES 127 Post marketing experience 127 2.5.6. Discussion on clinical safety 127 2.5.7. Conclusions on clinical safety 135 2.6. Risk Management Plan 135 2.7. New Active Substance 139 2.8. Product information 139 2.8.1. User consultation 139 2.8.2. Additional monitoring 139 3. Benefit risk assessment 139 3.1. Therapeutic Context 139 3.1.1. Disease or condition 139 3.1.2. Available therapies and unmet medical need 139 3.1.3. Main clinical studies

2018 European Medicines Agency - EPARs

154. Budesonide (Jorveza) - to treat adults with eosinophilic oesophagitis

Balance 76 3.1. Therapeutic Context 76 3.1.1. Disease or condition 76 3.1.2. Available therapies and unmet medical need 76 3.1.3. Main clinical studies 77 3.2. Favourable effects 77 3.3. Uncertainties and limitations about favourable effects 78 3.4. Unfavourable effects 79 3.5. Uncertainties and limitations about unfavourable effects 79 3.6. Effects Table 80 3.7. Benefit-risk assessment and discussion 81 3.7.1. Importance of favourable and unfavourable effects 81 3.7.2. Balance of benefits and risks (...) Assessment report EMA/774645/2017 Page 10/83 involved in the oesophageal barrier function (Desmoglein-1, Filaggrin). The damage caused by the chronic inflammation of the oesophageal epithelium promotes oesophageal remodelling processes which result in sub-epithelial fibrosis and the formation of strictures. 2.1.4. Clinical presentation, diagnosis and prognosis In adults and adolescents the disease is mainly diagnosed after presentation of the patients with dysphagia, pain on swallowing (odynophagia

2018 European Medicines Agency - EPARs

155. Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia

with S-K levels between 3.5 and 4.5 mmol/L but, more importantly, S-K levels between 4.5 and 5.0 mmol/L, which is within the normal range, were associated with a 2-fold increased risk of mortality compared with S-K between 3.5 and 4.5 mmol/L. 2.1.2. Epidemiology Hyperkalemia develops when there is insufficient elimination, excessive intake, or shift of potassium from the intracellular space. Insufficient elimination, which is the most common cause of hyperkalaemia, can be hormonal (as in aldosterone (...) deficiency), pharmacologic (e.g. treatment with angiotensin-converting enzyme inhibitors [ACEs], angiotensin-receptor blockers [ARBs], mineralocorticoid receptor antagonists) or, most commonly, due to reduced kidney function. Often, the cause is multifactorial (e.g. reduced kidney function combined with drug treatment such as ACEs or ARBs). Increased extracellular potassium levels result in depolarization of the membrane potential of cells. This depolarization opens some voltage gated sodium EMA/93250

2018 European Medicines Agency - EPARs

156. Rucaparib camsylate - Ovarian Neoplasms

2.10. Product information 157 2.10.1. User consultation 157 2.10.2. Additional monitoring 158 3. Benefit-Risk Balance 158 3.1. Therapeutic Context 158 3.1.1. Disease or condition 158 3.1.2. Available therapies and unmet medical need 158 3.2. Favourable effects 158 3.3. Uncertainties and limitations about favourable effects 159 3.4. Unfavourable effects 159 3.5. Uncertainties and limitations about unfavourable effects 160 3.6. Effects Table 160 3.7. Benefit-risk assessment and discussion 161 3.7.1 (...) acid DSB double-strand breaks DSC differential scanning calorimetry DVS dynamic vapour sorption EC European Commission ECG(s) electrocardiogram(s) ECOG Eastern Cooperative Oncology Group EMA European Medicines Agency EOC epithelial ovarian cancer ESMO European Society for Medical Oncology EU European Union EU-RMP European Union Risk Management Plan FDA Food and Drug Administration FeSSIF Fed state simulated intestinal fluid Assessment report EMA/CHMP/238139/2018 Page 5/167 FFPE formalin-fixed

2018 European Medicines Agency - EPARs

157. Glibenclamide (Amglidia) - Diabetes Mellitus

4/60 3.1.1. Disease or condition 49 3.1.2. Available therapies and unmet medical need 49 3.1.3. Main clinical studies 50 3.2. Favourable effects 51 3.3. Uncertainties and limitations about favourable effects 52 3.4. Unfavourable effects 52 3.5. Uncertainties and limitations about unfavourable effects 52 3.6. Effects Table 53 3.7. Benefit-risk assessment and discussion 56 3.7.1. Importance of favourable and unfavourable effects 56 3.8. Balance of benefits and risks 57 3.9. Additional (...) in the short term for patients with diabetes caused by KCNJ11 mutations and is probably more effective than insulin therapy. This pharmacogenetic response to sulphonylureas may result from the closing of mutant KATP channels, thereby increasing insulin secretion in response to incretins and glucose metabolism." The conclusion of the second article (Babenko et al. NEJM, 2006) was that "Dominant mutations in ABCC8 accounted for 12 percent of cases of neonatal diabetes in the study group. Diabetes results

2018 European Medicines Agency - EPARs

158. Dolutegravir sodium rilpivirine hydrochloride (Juluca) - HIV Infections

. Conclusions on the clinical efficacy 75 2.6. Clinical safety 75 2.6.1. Discussion on clinical safety 98 2.6.2. Conclusions on the clinical safety 100 2.7. Risk Management Plan 100 2.8. Pharmacovigilance 103 2.9. Product information 103 2.9.1. User consultation 103 Assessment report EMA/243517/2018 Page 3/109 3. Benefit-Risk Balance 103 3.1. Therapeutic Context 103 3.1.1. Disease or condition 103 3.1.2. Available therapies and unmet medical need 104 3.1.3. Main clinical studies 104 3.2. Favourable effects (...) and that the mean duration of use of the ART- regimen at screening was almost 4 years. Moreover, relevant comorbidities, such as CHB-infection and co-medications were excluded. Self-reported adherence to study medications was – with intake of 98% of the doses- unusually high. It is not clear, if outside a study setting and in a less stringently selected population the regimen’s efficacy would be the same. Study 201674 and Study 201676 The data indicate a difference in the relevant PK parameters of RPV

2018 European Medicines Agency - EPARs

159. Adalimumab (Hyrimoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Papulosquamous Skin Diseases, Hidradenitis Suppurativa, Ankylosing Spondylitis, Uveitis

5.1 and 5.2). 4 Crohn’s disease Hyrimoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who (...) to or have medical contraindications for such therapies. Uveitis Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate

2018 European Medicines Agency - EPARs

160. Sufentanil citrate (Dzuveo) - Pain

2.8.2. Labelling exemptions 79 3. Benefit-risk balance 80 3.1. Therapeutic Context 80 3.1.1. Disease or condition 80 3.1.2. Available therapies and unmet medical need 80 3.1.3. Main clinical studies 80 3.2. Favourable effects 80 3.3. Uncertainties and limitations about favourable effects 81 3.4. Unfavourable effects 81 3.5. Uncertainties and limitations about unfavourable effects 82 3.6. Effects Table 82 3.7. Benefit-risk assessment and discussion 83 3.7.1. Importance of favourable and unfavourable (...) : Sufentanil 30 µg sublingual tablet is indicated for the management of acute moderate to severe pain in adult patients in a medically supervised setting (see section 4.2.). The legal basis for this application refers to: Hybrid application (Article 10(3) of Directive No 2001/83/EC). The application submitted is composed of administrative information, complete quality data, a bioavailability study with the reference medicinal product Sufenta Forte Solution for injection 0.05mg/ml and appropriate non

2018 European Medicines Agency - EPARs

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