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Medication Causes of Dyspepsia

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161. Otitis externa

the application of topical medication. Follow up of otitis externa is not usually necessary, however, it is recommended for people with severe otitis externa, chronic otitis externa, diabetes mellitus or compromised immunity. Management of localized otitis externa includes: Advising people to apply local heat using a warm flannel — this may be sufficient, as folliculitis is usually mild and self-limiting. Considering incision and drainage if pus is causing severe pain and swelling — this usually requires (...) , or Candida albicans. Deeper infections (of the stratum corneum) are due to epidermophyton, trichophyton, or microsporum genera. Seborrhoeic dermatitis — this may affect the ears in isolation, or be associated with one or more of the following: dandruff, eyebrow scaling, blepharitis, or facial redness and scaling. Contact dermatitis — this is caused by a local irritant or allergen, such as topical medications (for example neomycin ear drops), hearing aids, or earplugs. Allergic contact dermatitis usually

2017 NICE Clinical Knowledge Summaries

162. Breastfeeding problems

incidence of obesity. Breastfeeding problems which may lead to a mother stopping breastfeeding include: Breast pain. Nipple pain. Low milk supply (true and perceived). Oversupply of milk. Breastfeeding problems may have a number of underlying causes, and more than one problem may co-exist at the same time. Assessment should include history and examination of both the mother and infant, including observation of the woman breastfeeding and expressing milk by a person with appropriate training (...) , if appropriate. Treatment of any skin conditions or other underlying causes of symptoms, if present. Arranging a paediatric referral for the infant if there are concerns about dehydration, faltering growth, infant development, or the presence of an anatomical abnormality such as ankyloglossia (tongue-tie) that may be affecting infant attachment and feeding. Considering specialist referral for possible drug treatment if Raynaud's disease of the nipple, or prolactin deficiency causing a low milk supply

2017 NICE Clinical Knowledge Summaries

163. Delirium

. [ ; ; ; ; ; ; ; ; ; ; ] Precipitating factors What factors can precipitate delirium? The cause of delirium is usually multifactorial [ ; ]. In people with , a relatively benign additional factor, for example a single dose of hypnotic medication, may precipitate delirium [ ]. Precipitating factors include: Infection such as urinary tract infection, infected pressure sore, or pneumonia. Metabolic disturbance such as hypoglycaemia, hyperglycaemia (including advanced carcinomatosis), or electrolyte abnormalities (including that due (...) or have failed, and The person is a danger to themselves or others, and The cause of delirium is known and being treated, and The benefit outweighs the risk to the person, and There is enough care in place for the person to be continually monitored. The following medication may be suggested: Short-term (for 1 week or less) low-dose haloperidol (off-label indication) [ ; ; ; ]. Low-dose lorazepam (off-label indication) as an alternative if haloperidol is contraindicated (for example in people

2017 NICE Clinical Knowledge Summaries

164. Asthma

. February 2011 — minor update. The range of dry powder inhaler devices included as prescriptions has been updated. Issued in February 2011. December 2010 — minor update. The Flixotide Diskhaler ® (fluticasone) range has been discontinued. The prescription has been removed. Issued in December 2010. October 2010 — minor update. Information on fitness to drive from the Driver and Vehicle Licensing Agency's guidance for medical practitioners, At a glance guide to the current medical standards of fitness (...) asthma guidelines . British Medical Journal. [ ] BMJ (2018) Improving the global diagnosis and management of asthma in children . British Medical Journal. [ ] Busse, W., et al. (2018) Combined analysis of asthma safety trails of long-acting ß 2 -agonists. The New England Journal of Medicine. [ ] NIHR (2018) Increasing inhaled steroids for short periods reduces asthma exacerbations. National Institute for Health Research [ ] Connett, G., Connett, L., and Thomas, M. (2019) Determining the reasons

2017 NICE Clinical Knowledge Summaries

165. Candida - female genital

Candida - female genital Candida - female genital - NICE CKS Clinical Knowledge Summaries Share Candida - female genital: Summary Vulvovaginal candidiasis (genital thrush) is a symptomatic inflammation of the vagina and/or vulva caused by a superficial fungal infection. Most cases are caused by a Candida yeast, although other yeasts are occasionally implicated. Vulvovaginal candidiasis infection can be classified as: Uncomplicated, which is sporadic or infrequent, mild to moderate, likely (...) management of vulvovaginal candidiasis (genital thrush). This CKS topic does not cover the management of other causes of vaginal discharge and itching. There are separate CKS topics on , , , , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes Changes May 2017 — minor update. The prescribing information section has been

2017 NICE Clinical Knowledge Summaries

166. Nouriast (istradefylline)

convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Report February 22, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product submitted for registration are as follows. [Brand name (...) to collect post-marketing information on the occurrence of psychiatric symptoms and dyskinesias, safety and efficacy in patients treated with 40 mg of istradefylline, safety in smokers, patients with hepatic impairment, patients with ischemic heart disease, and patients with respiratory disorders, and potential risks such as psychological dependence and lung toxicity. As a result of its regulatory review, the Pharmaceuticals and Medical Devices Agency has concluded that the product may be approved

2013 Pharmaceuticals and Medical Devices Agency, Japan

167. Lyxumia (lixisenatide)

and that this result should be reported to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council. The re-examination period for the product is 8 years, and the drug substance and the drug product are both classified as powerful drugs and the product is not classified as a biological product or a specified biological product. The proposed Japanese brand name should be changed for ensuring medical safety. *Japanese Accepted Name (modified INN) This English version (...) of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Report May 7, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following

2013 Pharmaceuticals and Medical Devices Agency, Japan

168. Acofide (acotiamide hydrochloride hydrate)

, and early satiation in patients with functional dyspepsia has been demonstrated and its safety is acceptable. As a result of its regulatory review, the Pharmaceuticals and Medical Devices Agency has concluded that the product may be approved for the following indication and dosage and administration. [Indication] Postprandial fullness, upper abdominal bloating, and early satiation in patients with functional dyspepsia [Dosage and administration] The usual adult dosage is 100 mg of acotiamide (...) , the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Report January 25, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product submitted for registration are as follows. [Brand name] Acofide Tablets 100 mg [Non-proprietary name] Acotiamide Hydrochloride Hydrate [Applicant] Zeria Pharmaceutical Co

2013 Pharmaceuticals and Medical Devices Agency, Japan

169. Perjeta (pertuzumab (genetical recombination))

will not be responsible for any consequence resulting from the use of this English version. Review Report April 9, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product submitted for registration are as follows. [Brand name] Perjeta Intravenous Infusion 420 mg/14 mL [Non-proprietary name] Pertuzumab (Genetical Recombination) [Applicant] Chugai Pharmaceutical Co., Ltd. [Date of application (...) as the efficacy of the product in Japanese patients need to be further investigated in the clinical studies. As a result of its regulatory review, the Pharmaceuticals and Medical Devices Agency has concluded that the product may be approved for the following indication and dosage and administration. [Indication] HER2-positive inoperable or recurrent breast cancer [Dosage and administration] In concomitant use with trastuzumab (genetical recombination) and other antineoplastic drugs, the usual loading dose

2013 Pharmaceuticals and Medical Devices Agency, Japan

170. Kadcyla (trastuzumab emtansine (genetical recombination))

with chemotherapy or who progressed after chemotherapy including HER2-targeted treatment (target sample size, 60) in 17 medical institutions overseas. Of 67 patients enrolled in the study, 64 patients received the study drug and were included in the safety analysis. Death was reported in 1 patient within 30 days after the last dose of the study drug. The death was caused by pneumonia and its causal relationship to the study drug was ruled out. 2) Foreign phase II study (5.3.5.1.2, Study TDM4450g/Study BO21976 (...) report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Report August 15, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product

2013 Pharmaceuticals and Medical Devices Agency, Japan

171. Xeljanz (tofacitinib citrate)

, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Report February 28, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product submitted for registration are as follows. [Brand name] Xeljanz Tablets 5 mg [Non-proprietary name] Tofacitinib Citrate [Name of applicant] Pfizer Japan Inc. [Date (...) of the product (including the detection of unknown adverse events) as soon as possible. Furthermore, a surveillance study to follow patients during long-term treatment for the occurrence of serious infections and malignancies, etc. should be conducted. As a result of its review, the Pharmaceuticals and Medical Devices Agency has concluded that the product may be approved for the indication and the dosage and administration as shown below, with the following conditions. [Indication] Rheumatoid arthritis

2013 Pharmaceuticals and Medical Devices Agency, Japan

172. Giardia lamblia infection increases risk of chronic gastrointestinal disorders (PubMed)

with documented G. lamblia infection were assessed for the subsequent risk of developing a chronic GI disorder including irritable bowel syndrome (IBS), dyspepsia and gastroesophageal reflux disease (GERD). Post-giardia chronic GI disorder risk was compared to risk in uninfected personnel matched on several demographic characteristics and medical encounter information. Data were obtained from the Defense Medical Surveillance System and exposures (1998-2009) with outcomes identified based on documented medical (...) Giardia lamblia infection increases risk of chronic gastrointestinal disorders Giardia lamblia is a common parasitic cause of infectious gastroenteritis in the United States and the world and may be linked to an increased risk of chronic gastrointestinal (GI) disorders. We sought to assess the risk of several chronic GI disorders following Giardia infection among active duty US military personnel.This study was designed as a retrospective cohort study in which active duty military personnel

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2016 Tropical diseases, travel medicine and vaccines

173. Dimethyl fumarate (Skilarence) - plaque psoriasis

. Clinical safety 76 2.6.1. Discussion on clinical safety 87 2.6.2. Conclusions on the clinical safety 90 2.7. Risk Management Plan 91 2.8. Pharmacovigilance 97 2.9. Product information 97 Assessment report EMA/412737/2017 Page 3/108 2.9.1. User consultation 97 3. Benefit-Risk Balance 98 3.1. Therapeutic Context 98 3.1.1. Disease or condition 98 3.1.2. Available therapies and unmet medical need 98 3.1.3. Main clinical studies 98 3.2. Favourable effects 99 3.3. Uncertainties and limitations about (...) Analysis of covariance AST Aspartate aminotransferase ATC Anatomical Therapeutic Chemical AUC0-8 Area under the plasma concentration-time curve from time zero to infinity AUC0-t Area under the plasma concentration-time curve from time zero to time t, where t is the time of the last concentration measured BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (the German Federal Institute for Drugs and Medical Devices) BID Twice Daily BSA Body surface area CHMP Committee for Medicinal Products

2017 European Medicines Agency - EPARs

174. Pentosan polysulfate sodium (Elmiron) - Interstitial Cystitis

. Conclusions on the clinical efficacy 96 2.6. Clinical safety 97 2.6.1. Discussion on clinical safety 102 2.6.2. Conclusions on the clinical safety 103 2.7. Risk Management Plan 104 2.8. Pharmacovigilance 106 2.9. Product information 106 Assessment report EMA/287422/2017 Page 3/115 2.9.1. User consultation 106 3. Benefit-Risk Balance 106 3.1. Therapeutic Context 106 3.1.1. Disease or condition 106 3.1.2. Available therapies and unmet medical need 107 3.1.3. Main clinical studies 107 3.2. Favourable effects (...) bladder. Up to 50% of patients with symptoms of interstitial cystitis will have spontaneous resolution in time. 2.1.3. Aetiology and pathogenesis There are many and different hypotheses about the causes of IC, including infection, inflammation, autoimmune mechanisms, hormonal troubles, defects in the urothelial glycosaminoglycan layer, hypoxia, and central neurologic mechanisms. Assessment report EMA/287422/2017 Page 10/115 The aetiology is unknown but some triggering factors such as certain acid

2017 European Medicines Agency - EPARs

175. Clinical practice guideline for the management of patients with Parkinson´s disease

subcutaneous infusions of apomorphine may be used to reduce off time and dyskinesia in persons with PD and severe motor complications. This should only be initiated in expert units with facilities to allow adequate supervision. Management of problems related to antiparkinson medications Drug-induced psychosis D All persons with PD and psychosis should receive a general medical evaluation, in order to exclude other treatable causes of psychosis. D Before considering the use of anti-psychotic medication (...) the product sheet: http://www. aemps.gob.es/ D The use of low doses of quetiapine may be considered as an alternative anti- psychotic to clozapine for the treatment of patients with psychosis in PD, when weekly routine blood monitoring is not possible, and within the framework of Royal Decree 1015/2009, dated 19 June, regulating the availability of medications in special situations. Sleep disorders D The treatment of Excessive Daytime Sleepiness (EDS) must be aimed at finding a reversible cause

2015 GuiaSalud

176. Niraparib (Zejula) - Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms

in the first-line setting is platinum (cisplatin or carboplatin) plus a taxane (paclitaxel or docetaxel) with or without bevacizumab. However, platinum-based chemotherapy can cause serious side effects this may negatively impact patients’ ability to lead a productive life. Once a patient has recurrence of their ovarian cancer, chemotherapy is an option for reducing disease-related symptoms. Both the National Comprehensive Cancer Network and European Society for Medical Oncology guidelines recommend re (...) . Discussion on clinical safety 106 2.6.2. Conclusions on the clinical safety 110 2.7. Risk Management Plan 110 2.8. New Active Substance 113 2.9. Product information 113 2.9.1. User consultation 113 2.9.2. Additional monitoring 113 Assessment report EMA/648982/2017 Page 3/122 3. Benefit-Risk Balance 114 3.1. Therapeutic Context 114 3.1.1. Disease or condition 114 3.1.2. Available therapies and unmet medical need 114 3.1.3. Main clinical studies 115 3.2. Favourable effects 115 3.3. Uncertainties

2017 European Medicines Agency - EPARs

179. Maviret (glecaprevir / pibrentasvir) - chronic (long-term) hepatitis C

. Conclusions on clinical efficacy 103 2.6. Clinical safety 103 2.6.1. Discussion on clinical safety 111 2.6.2. Conclusions on the clinical safety 112 2.7. Risk Management Plan 113 2.8. Pharmacovigilance 116 2.9. New Active Substances 116 2.10. Product information 117 Assessment report EMA/449689/2017 Page 3/126 2.10.1. User consultation 117 2.10.2. Additional monitoring 117 3. Benefit-Risk Balance 117 3.1. Therapeutic Context 117 3.1.1. Disease or condition 117 3.1.2. Available therapies and unmet medical (...) persons are chronically infected with HCV throughout Europe. The prevalence of HCV in the general adult population ranges from =0.5% (Northern European countries) to =3% (Greece, Italy, and Eastern European countries). It is the most common single cause of liver transplantation in the European Union. Depending on various risk factors, between 10-40% of patients with chronic HCV infection will develop cirrhosis over time. Death related to the complications of cirrhosis (mainly liver decompensation

2017 European Medicines Agency - EPARs

180. Tofacitinib (Xeljanz) - Rheumatoid arthritis

component summary MedDRA Medical Dictionary for Regulatory Activities MMF Mycophenolate mofetil MOA mechanism of action MTX Methotrexate MTX-IR Methotrexate-inadequate responder mTSS modified Total Sharp Score NHL non-Hodgkin's lymphoma NMSC nonmelanoma skin cancer NK natural killer NSAID(s) Nonsteroidal Anti-Inflammatory Drug(s) PBO placebo PD Pharmacodynamics PK Pharmacokinetic PRAC Pharmacovigilance Risk Assessment Committee PRL prolactin PRO patient reported outcomes PT Preferred Term PT LD post (...) active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Rheumatoid arthritis (RA) is a chronic immune-mediated inflammatory disease that causes progressive damage to small and large joints (termed structural progression). 2.1.2. Epidemiology and risk factors Rheumatoid arthritis

2017 European Medicines Agency - EPARs

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