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Medication Causes of Dyspepsia

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161. 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)

162. 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

163. 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

164. 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

165. 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

166. 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

167. 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

168. 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

169. 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

170. 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

171. 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

172. The opioid ‘crisis’: the pendulum swings again by Amelia Swift

The opioid ‘crisis’: the pendulum swings again by Amelia Swift The opioid 'crisis': the pendulum swings again by Amelia Swift | Evidence-Based Nursing blog by The term ‘opioid epidemic’ or ‘opioid crisis’ refers to a surge in the rate of substance use disorder and escalation of overdose deaths that has been declared a Public Health Emergency in the US (Roehr 2017). Drug overdose has become the leading cause of preventable death in the US, and the rate of opioid overdose deaths has increased (...) century. Opium, morphine, and later heroin were widely available and marketed for a host of disorders and ailments including the control of insanity, alleviation of cough, treatment of communicable diseases such as malaria, management of asthma, dyspepsia and hypochondriasis (Leigh 1785). Medicine was a highly competitive field and doctors needed to impress and retain patients to make a living. Effective remedies and treatments were limited, and morphine often alleviated troubling symptoms meaning

2018 Evidence-Based Nursing blog

173. 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

174. 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

175. Lonoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V

– Addendum to Commission A16-32 9 November 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of figures Page Figure 1: Kaplan-Meier curve for the outcome “all-cause mortality” – RCT, direct comparison: elotuzumab + lenalidomide + low-dose dexamethasone vs. lenalidomide + low-dose dexamethasone (data cut-off: 29 October 2015) 25 Addendum A16-66 Version 1.0 Elotuzumab – Addendum to Commission A16-32 9 November 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - vi (...) infection 32 (10.1) 18 (5.7) Gastrointestinal disorders 256 (80.5) 214 (67.5) Diarrhoea 152 (47.8) 118 (37.2) Constipation 114 (35.8) 88 (27.8) Nausea 78 (24.5) 70 (22.1) Vomiting 52 (16.4) 29 (9.1) Abdominal pain 44 (13.8) 29 (9.1) Dyspepsia 33 (10.4) 19 (6.0) Musculoskeletal and connective tissue disorders 223 (70.1) 217 (68.5) Muscle spasms 96 (30.2) 84 (26.5) Back pain 95 (29.9) 91 (28.7) Arthralgia 63 (19.8) 46 (14.5) Pain in extremity 56 (17.6) 32 (10.1) Musculoskeletal pain 45 (14.2) 30 (9.5

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

176. Brivaraceta

comparison: brivaracetam vs. lacosamide 17 Table 10: Results on all-cause mortality, side effects – RCT, indirect comparison: brivaracetam vs. lacosamide 20 Table 11: Positive and negative effects for brivaracetam in the indirect comparison with lacosamide 27 Table 12: Study N01254, common AEs (in the SOC and in the PT = 2% in at least one study arm) – RCT, indirect comparison: brivaracetam vs. lacosamide 29 Table 13: Study N01254, SAEs – RCT, indirect comparison: brivaracetam vs. lacosamide .. 31 Table (...) to be in place = 6 months before study inclusion ? Anxiolytic and hypnotic drugs were allowed in a stable and low dosage Rescue medication Benzodiazepines were allowed once each during the titration phase and the maintenance period (3 doses in a 24-hour period), except during the 8-week baseline period. During the down-titration phase, the investigator decided on the administration. Prohibited prior and concomitant treatment (4 weeks before screening and during the entire study period) ? non-oral AEDs

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

177. Cancer Pain (PDQ®): Health Professional Version

. (Refer to the section of this summary for more information). Is the pain acute or chronic? Is it secondary to cancer, cancer treatment, other causes, or a combination? Is it somatic, visceral, neuropathic, or mixed? Is there an incidental component? Is there breakthrough pain? Determining whether the pain requires pharmacologic and/or other modalities of treatment. Pain is often multifactorial in nature, so factors that may modulate pain expression, such as psychological distress and substance use (...) evaluation and intervention. There are many issues to consider when determining the most appropriate treatment, such as the following: Previous pain treatments. Patient prognosis. Predictive factors for pain control (e.g., psychological distress). Impact on function. Comorbidities (e.g., renal or hepatic failure). Risk of misuse of or addiction to pain medications. Patient preference. Providing proper education about treatment, including medication administration, expected side effects and associated

2017 PDQ - NCI's Comprehensive Cancer Database

178. Prevention of chemotherapy induced nausea and vomiting in adults: netupitant/palonosetron

and vomiting are distressing side effects of chemotherapy. Chemotherapy regimens vary in the extent to which they cause nausea and vomiting (usually classed as having a minimal, low, moderate or high degree of emetogenicity). For example, the Multinational Association for Supportive Care in Cancer (MASCC) and the European Society of Medical Oncology (ESMO) antiemetic guidelines classify the following (if given intravenously) as moderately emetogenic: cyclophosphamide (at doses of less than 1500 mg/m 2 (...) Effectiveness eness During the delayed phase of the first cycle of an anthracycline plus cyclophosphamide chemotherapy regimen, statistically significantly more participants taking netupitant/palonosetron 300 mg/500 microgram had a complete response (no emesis and no rescue medication) and no significant nausea compared with palonosetron 500 microgram (complete response: 76.9% compared with 69.5%; and no significant nausea: 76.9% compared with 71.3% respectively) [1 RCT; n=1455]. During the overall phase

2016 National Institute for Health and Clinical Excellence - Advice

179. Chronic prostatitis and chronic pelvic pain syndrome

Saxty, 8 Sarah Mee, 9 Alison Cooper, 10 Kirsty Haves, 11 and Jenny Lee 12 1 GP (Chair of Prostatitis Expert Reference Group), Backwell and Nailsea Medical Group, Bristol; 2 Pain Consultant, Addenbrooke’s Hospital, Cambridge; 3 Clinical Nurse Specialist – Prostate, University College London Hospitals, London; 4 Patient Representative; 5 Consultant Urologist, Addenbrooke’s Hospital, Cambridge; 6 Urology Clinical Nurse Specialist, South Warwickshire Foundation Trust; 7 Physiotherapist Specialist (...) , Addenbrooke’s Hospital, Cambridge; 8 Cognitive Behavioural Therapist, Addenbrooke’s Hospital, Cambridge; 9 Policy and Evidence Manager, Prostate Cancer UK; 10 Senior Research Analyst, Prostate Cancer UK; 11 Senior Account Manager, Hayward Medical Communications; 12 Project Manager, Hayward Medical Communications A quick reference guide version of this guideline can be downloaded from: www.prostatecanceruk.org/prostatitisguideline ENDORSED BY September 2014 (due for review September 2017) Diagnosis

2015 Prostate Cancer UK

180. Stretta System for gastro-oesophageal reflux disease

://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 15Current NHS options The NICE guideline on gastro-oesophageal reflux disease and dyspepsia in adults recommends lifestyle modifications such as weight reduction or smoking cessation, and gastric acidity-lowering medication to improve symptoms. People whose symptoms do not respond to medication or lifestyle changes, who develop complications despite medication, or who develop intolerance to medication may be considered for anti-reflux surgery (...) Heartburn commented that reflux is a very common complaint, but when it is persistent and longstanding there should be careful investigation to find the underlying causes. This is especially important for conditions such as Barrett's oesophagus, which can develop into oesophageal adenocarcinoma. The organisation stated that there is concern about the long-term effects of PPI medication on some people, despite their short-term effectiveness, and also concern about patients for whom PPI medication does

2016 National Institute for Health and Clinical Excellence - Advice

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