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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 (...) according to §35a Social Code Book V [1]). In its dossier [2], the pharmaceutical company (hereinafter referred to as “the company”) had used the results of a subpopulation of a randomized controlled trial (RCT) (POLARIS-2) for the assessment of the added benefit of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for adults with chronic hepatitis C (CHC) genotype 2 and without cirrhosis (research question 2.1) and for adults with CHC genotype 3 and without cirrhosis (research question 3.1

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

162. Ovarian Cancer Awareness Update: 2019 Gynaecological Cancer Update

are at population risk of ovarian cancer, and surveillance of women at high or potentially high risk of ovarian cancer. There is currently no evidence to support using any screening test to look for ovarian cancer in women who do not have symptoms. Know your body and be ovarian cancer aware social media campaign Ovarian Cancer Awareness Month in February provides the opportunity to focus on ovarian cancer, the second most common gynaecological cancer and the most common cause of gynaecological cancer death (...) after uterine cancer in Australia. 1 It is estimated that ovarian cancer will be the most common cause of death from gynaecological cancer in Australia during 2019, with approximately 1,046 deaths predicted. 1 While the five year relative survival rate for ovarian cancer has improved from 36% in 1986 – 1990 to 46% in 201 1-2015, it remains low in comparison with other cancers. This means that 46 out of 100 women diagnosed with ovarian cancer survive five years or more after their diagnosis. 1

2019 Cancer Australia

163. Bariatric surgery: an HTA report on the efficacy, safety and cost-effectiveness

Note that these SOS trial data stem from a time period where overall mortality and complications are in general higher than what is seen in contemporary bariatric medicine. Three relatively recent systematic reviews and meta-analyses (SR-MA) provided relative risk reductions after MBS in all-cause mortality varying between -41% and -52%. 88, 89, 93 These three SR-MA had some overlap, explained by the slightly different eligibility criteria and their different time of periods. The results (...) and lifestyle modifications, there is increasing interest in performing MBS in adolescents with severe or morbid obesity, especially in those at very high risk or those with associated co- morbidities like hypertension, diabetes and non-alcoholic steatohepatitis (NASH), as well as in those with extreme BMI values, who cannot be managed successfully otherwise. A particular medical challenge constitute children and adolescents with monogenic traits causing morbid or super- obesity. Psychopathology and social

2019 Belgian Health Care Knowledge Centre

164. Managing GORD with PPIs in primary care Full Text available with Trip Pro

and sponsored by the Gastroenterological Society of Australia (GESA). It is the fifth edition of these guidelines, and was initially planned to be updated again in 2013/2014. The Gastrointestinal drugs chapter of the Australian Medicines Handbook has a section on GORD. Clinical guideline CG184 was developed by the National Institute for Health and Care Excellence (NICE) in the UK. It covers the investigation and management of GORD and dyspepsia in people aged 18 and over. It also makes detailed (...) Managing GORD with PPIs in primary care Managing GORD with PPIs in primary care | NPS MedicineWise 20 Years Of Helping Australians Make Better Decisions About Medicines, Medical Tests And Other Health Technologies. Log in Facebook Twitter LinkedIn Google Signing you in Use another account OR Login Form Email Password Log in to NPS MedicineWise Forgot password Forgot password Email Send reset instructions Set new password Reset Password Password Set password Account exists We found an existing

2019 National Prescribing Service Limited (Australia)

165. Finasteride

Academy of Dermatology J. Am. Acad. Dermatol. A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride (...) in the treatment of male subjects with androgenetic alopecia. 489-498.e3 10.1016/j.jaad.2013.10.049 S0190-9622(13)01171-7 Dihydrotestosterone is the main androgen causative of androgenetic alopecia, a psychologically and physically harmful condition warranting medical treatment. We sought to compare (...) the risk of sexual dysfunction is higher among individuals treated with finasteride compared to a baseline risk for all other drugs using the U.S. Food and Drug Administration Adverse Event Reporting (...) System (FAERS) database. METHODS: A case by non-case disproportionality approach was used whereby a Reporting Odds Ratio (ROR) with 95% confidence interval (CI) was calculated. The National Ambulatory Medical Care Survey (NAMCS) was used to confirm results. RESULTS: A significant disproportionality

2018 Trip Latest and Greatest

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

an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis (...) in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Psoriasis Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque

2018 European Medicines Agency - EPARs

167. Ranitidine

Coronary Artery Disease: A Double-Blind, Double Dummy, Randomized Study. 275-84 10.1007/s40256-016-0172 (...) -5 Proton-pump inhibitors (PPIs) are often prescribed to patients receiving dual antiplatelet therapy (DAPT). However, this class of medication, especially omeprazole, has been associated with a reduction in clopidogrel efficacy, leading many clinicians to substitute omeprazole with ranitidine . Our objective was to compare the antiplatelet effect of clopidogrel before and after the addition (...) Clarithromycin therapeutic use Drug Therapy, Combination Female Gastrointestinal Diseases drug 2001 15. Meta-analyses of cisapride, omeprazole and ranitidine in the treatment of GORD: implications for treating patient subgroups Meta-analyses of cisapride, omeprazole and ranitidine in the treatment of GORD: implications for treating patient subgroups Meta-analyses of cisapride, omeprazole and ranitidine in the treatment of GORD: implications for treating patient subgroups Iskedjian M, Einarson T R Authors

2018 Trip Latest and Greatest

168. Proton pump inhibitors

the small number of studies. Authors' objectives To evaluate the effectiveness of proton pump inhibitors compared to histamine-2 receptor antagonists in the prevention of stress 2009 8. Proton pump inhibitors for functional dyspepsia. BACKGROUND: Functional dyspepsia (FD or non-ulcer dyspepsia) is defined as continuous or frequently recurring epigastric pain or discomfort for which no organic cause can be found. Acid suppressive therapy, including proton pump inhibitors ( PPIs ), has been proposed (...) or peptic ulcer disease | Therapeutics Initiative Independent Healthcare Evidence > > A systematic review of the comparative effectiveness of proton pump inhibitors (...) for the treatment of adult patients with gastroesophageal reflux disease or peptic ulcer disease This was produced by the Drug Assessment Working Group of the Therapeutics Initiative at the request of the Pharmaceutical Services Division (PSD) of the British Columbia Ministry of Health as part of the Drug Effectiveness Review Project

2018 Trip Latest and Greatest

169. Sufentanil citrate (Dzuveo) - Pain

-ventilated area. 2.2.3. Finished medicinal product Description of the product and Pharmaceutical development The finished product is a blue-coloured flat-faced immediate release sublingual tablet with rounded edges containing sufentanil citrate equivalent to 30 µg sufentanil. It is 3 mm in diameter and 0.85 mm thick with a nominal tablet weight of 7.40 mg. The finished drug product is defined as a single sufentanil sublingual 30 µg tablet packaged in a polypropylene single dose applicator (SDA) in a PE (...) substance 9 General information 9 Manufacture, characterisation and process controls 10 Specification 10 Stability 11 2.2.3. Finished medicinal product 11 Description of the product and Pharmaceutical development 11 Manufacture of the product and process controls 13 Product specification 13 Stability of the product 14 Adventitious agents 14 2.2.4. Discussion on chemical, and pharmaceutical aspects 14 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendations

2018 European Medicines Agency - EPARs

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

of the dossier 7 1.2. Steps taken for the assessment of the product 8 2. Scientific discussion 8 2.1. Problem statement 8 2.1.1. Disease or condition 8 2.1.2. Epidemiology 9 2.1.3. Biologic features, Aetiology and pathogenesis 9 2.1.4. Clinical presentation, diagnosis and prognosis 10 2.1.5. Management 10 2.2. Quality aspects 13 2.2.1. Introduction 13 2.2.2. Active Substance 14 2.2.3. Finished Medicinal Product 15 2.2.4. Discussion on chemical and pharmaceutical aspects 17 2.2.5. Conclusions on the chemical (...) 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

2018 European Medicines Agency - EPARs

171. Depression

be as effective as medication Adequate may significantly improve depressive symptoms Spiritual distress may be a component of depression, or distinct from it Consider supportive psychotherapy or cognitive behavioural therapy Patients with severe depression and/or suicidal ideation are uncommon but should be referred to psychological medicine/psychiatry for assessment. Medication There is no evidence of superior efficacy for a particular antidepressant agent. A current or previously effective antidepressant (...) /escitalopram : Tablet and oral suspension available. It is useful for agitated depression/anxiety and relatively safe if the patient is at risk of . There is a risk of QTc prolongation and drug interactions. Review concurrent medications, see British National Formulary Fluoxetine: It is long acting and offers low risk of withdrawal effects. It has many drug interactions so it may not be suitable in palliative care patients. Side effects include: , , dyspepsia, risk of gastrointestinal (GI) bleeding - avoid

2018 Scottish Palliative Care Guidelines

172. 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 (...) glucose lowering drugs, excl. insulins, (A10BJ06) Therapeutic indications: Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections

2018 European Medicines Agency - EPARs

173. Rucaparib camsylate - Ovarian Neoplasms

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 (...) for Pharmaceuticals for Human Use INN International Nonproprietary Name IPC in-process control IR infrared IRR independent radiological review IV intravenous KF Karl Fischer titration LDPE low density polyethylene LPI last patient in MAA Marketing Authorization Application MAH marketing authorization holder MATE multidrug and toxin extrusion transporter MHRA Medicines and Healthcare products Regulatory Agency MDR1 multidrug resistance protein 1 MDS myelodysplastic syndrome MedDRA Medical Dictionary for Regulatory

2018 European Medicines Agency - EPARs

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

concentration prior to the beginning of a dosing C 24h Plasma concentration after 24 hours CAR Current antiretroviral regimen cART Combination antiretroviral therapy CFU Colony forming units CHMP Committee for Medicinal Products for Human use CI Confidence interval CL Systemic clearance of parent drug CL/F Apparent clearance following oral dosing CL/F/kg Apparent oral clearance adjusted for body weight C max Maximum concentration CMH Cochran-Mantel Haenszel C min Minimum observed concentration CPP (...) and pathogenesis 10 2.1.3. Biologic features 10 2.1.4. Clinical presentation, diagnosis 10 2.1.5. Management 11 2.2. Quality aspects 12 2.2.1. Introduction 12 2.2.2. Active Substance 12 2.2.3. Finished Medicinal Product 16 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 20 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.2.6. Recommendation for future quality development 20 2.3. Non-clinical aspects 20 2.3.1. Introduction 20 2.3.2. Pharmacology 21 2.3.3

2018 European Medicines Agency - EPARs

175. Glibenclamide (Amglidia) - Diabetes Mellitus

-proprietary name: glibenclamide Procedure No. EMEA/H/C/004379/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. CHMP assessment report EMA/153558/2018 Page 2/60 Administrative information Name of the medicinal product: Amglidia Applicant: Ammtek 15, rue Beranger 75003 Paris FRANCE Active substance: GLIBENCLAMIDE International Nonproprietary Name: glibenclamide Pharmaco-therapeutic group (ATC Code): BLOOD GLUCOSE LOWERING DRUGS, EXCL (...) : bottle (glass) Package size(s): 1 bottle + 1 bottle adapter + one oral syringe (1ml or 5ml) CHMP assessment report EMA/153558/2018 Page 3/60 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 1.2. Steps taken for the assessment of the product 9 2. Scientific discussion 11 2.1. Introduction 11 2.2. Quality aspects 12 2.2.1. Introduction 12 2.2.2. Finished medicinal product 14 Adventitious agents 17 2.2.3. Discussion on chemical, and pharmaceutical aspects

2018 European Medicines Agency - EPARs

176. Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia

presentation, diagnosis 8 2.1.4. Management 8 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 9 2.2.3. Finished Medicinal Product 12 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 14 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendations for future quality development 15 2.3. Non-clinical aspects 15 2.3.1. Introduction 15 2.3.2. Pharmacology 15 2.3.3. Pharmacokinetics 17 2.3.4. Toxicology 18 2.3.5. Ecotoxicity (...) 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

177. Diagnosis and management of gonorrhoea and syphilis

European Centre for Disease Prevention and Control EIA Enzyme immunoassays EMA European Medicines Agency EUCAST European Committee on Antibiotic Susceptibility Testing FDA US Food and Drug Administration FP False positive FN False negative FTA-ABS Fluorescent treponemal antibody absorption test GDG Guideline development group 12 Diagnosis and management of gonorrhoea and syphilis KCE Report 310 GRADE Grading of recommendations assessment, development and evaluation HIV Human Immunodeficiency Virus IM (...) KENYON, AGNES LIBOIS, SAPHIA MOKRANE, ELIZAVETA PADALKO, SANDRA VAN DEN EYNDE, WIM VANDEN BERGHE, THIERRY VAN DER SCHUEREN, NICOLE DEKKER COLOPHON Title: Diagnosis and management of gonorrhoea and syphilis Authors: Vicky Jespers (KCE), Sabine Stordeur (KCE), Anja Desomer (KCE), Serena Carville (NGC), Clare Jones (NGC), Sedina Lewis (NGC), Mark Perry (NGC), Sam Cordyn (Wit-Gele Kruis van Vlaanderen), Tine Cornelissen (Domus Medica), Tania Crucitti (Institute of Tropical Medicine(ITM)), Céline Danhier

2019 Belgian Health Care Knowledge Centre

178. Migalastat for treating Fabry disease

, and only if enzyme replacement therapy (ERT) would otherwise be offered. Criteria for starting and stopping ERT for Fabry disease are described in the UK adult Fabry disease standard operating procedures (Hughes et al. 2013). With the discount provided in the patient access scheme, migalastat has a lower total cost than ERT, and potentially provides greater health benefits than ERT. 1.2 The committee noted that there were important limitations and uncertainties in the evidence presented for migalastat (...) ://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 4 of 312 2 The condition The condition 2.1 Fabry disease is an inherited lysosomal storage disease caused by a non- functional or only partially functional enzyme, alpha-galactosidase A (alpha-gal A). Decreased activity of alpha-gal A in lysosomes results in the accumulation of enzyme substrates (Gb3 and lyso-Gb3) which cause cellular damage in tissues throughout the body. 2.2 Symptoms include pain that spreads through the body (called a Fabry

2017 National Institute for Health and Clinical Excellence - Highly specialised technology

179. Oral supplementation of iron: evolving best practices

In these settings, a clinician should first ask about adherence. Poor compliance is the leading cause of unsatisfactory responses to iron therapy, 7 likely due to the dyspepsia, constipation, and hard stools that frequently accompany supplementation with ferrous sulfate. A stool softener such as docusate is often prescribed to help with this problem. Absent such issues, a clinician may search for an unrecognized source of bleeding, or perhaps consider the presence of a gastrointestinal comorbidity that impairs (...) for a lackluster response to oral iron, intravenous supplementation therapy should be initiated. This route of administration bypasses the patient’s faulty enteric system, and has the added benefit of rapidly repleting physiologic iron stores. 10 Gabrielle Mayer is a medical student at NYU School of Medicine Peer reviewed by Bruce Raphael , MD, Clinical Professor, Division of Hematology/Oncology, NYU Langone Health Image courtesy of USDA.gov References Moretti D, Goede JS, Zeder C, et al. Oral iron supplements

2019 Clinical Correlations

180. Diagnosis and management of patients at risk of gastric adenocarcinoma Full Text available with Trip Pro

morphology and those causing symptoms (obstruction, bleeding) should be resected. If present, H. pylori should be eradicated before re-evaluation for endoscopic therapy (evidence level: low quality; grade of recommendation: weak; level of agreement: 100%). We suggest that enhanced endoscopic imaging is used to aid characterisation of gastric polyps when there is diagnostic uncertainty following white light examination (evidence level: low quality; grade of recommendation: weak; level of agreement: 93 (...) been suggested that this is not a cost-effective strategy. However, as recently argued by O’Connor et al , there may be additional benefits associated with H. pylori eradication, such as a reduction in peptic ulcer disease and dyspepsia, and these have not been considered in all the proposed economic models. Other potential consequences of widespread H. pylori eradication therapy should also be considered when considering the risk:benefit ratio of such a strategy. These include the potential

2019 British Society of Gastroenterology

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