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Emergency Medicine Treatment and Labor Act

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661. Shoulder pain

) or naproxen (1000 mg per day or less). Use the lowest effective dose and the shortest duration of treatment necessary to control symptoms. Co-prescribe a proton pump inhibitor (PPI) with NSAIDs for people with osteoarthritis or rheumatoid arthritis, and think about the use of gastroprotective treatment when prescribing NSAIDs for low back pain in accordance with NICE guidance. Take account of drug interactions when co-prescribing NSAIDs with other medicines (see Summaries of Product Characteristics (...) ). For example, co-prescribing NSAIDs with ACE inhibitors or angiotensin receptor blockers (ARBs) may pose particular risks to renal function; this combination should be especially carefully considered and regularly monitored if continued. Medicines optimisation in long-term pain Ensure people with long-term pain receive optimal pain treatment with careful consideration of the benefits and risks of treatment options. Assess risk and address harms of medicines where safety issues are a concern

2017 NICE Clinical Knowledge Summaries

662. Obesity

[ ]. Drug treatment plus lifestyle interventions can produce a small but statistically significant increase in weight loss, but long-term maintenance of the weight loss is also poor and adherence to treatment may be affected by possible adverse effects of the medication [ ]. There is good evidence that significant clinical benefits may be achieved even by modest weight loss (about 5–10% of initial body weight) and lifestyle modification (improved nutritional content of the diet and modest increases (...) and adherence to treatment may be affected by possible adverse effects of the medication [ ]. Expert opinion in the European Guidelines for Obesity Management in Adults is that cognitive behavioural therapy directly addresses behaviours that require change for successful weight loss and weight loss maintenance [ ]. Follow up NICE recommends that a person being managed for overweight or obesity should be offered regular, non-discriminatory long-term follow-up by a trained professional [ ]. Expert opinion

2017 NICE Clinical Knowledge Summaries

663. Colobreathe (colistimethate sodium)

is stated on the Certificate of Suitability if the drug substance is stored in a container consisting of aluminium bottle with PE insert and PP or PE lid. 2.2.3 Finished Medicinal Product Pharmaceutical Development The product has been developed in accordance with the requirements of the relevant guideline EMEA/CHMP/QWP/49313/2005 Corr. Guideline on the pharmaceutical quality of inhalation and nasal products. Formulation development of this dry powder delivery system was conducted to produce a more (...) conditions have been provided to support the shelf life and storage conditions as defined in the SmPC, There were no changes in uniformity of delivered dose, fine particle mass and uniformity of mass. All samples complied with the stability specification for average content of colistimethate sodium and microbial testing. Comparability Exercise for Finished Medicinal Drug Product Not applicable GMO Not applicable Colobreathe Assessment report Page 13/66 2.2.4 Discussion on chemical, pharmaceutical

2012 European Medicines Agency - EPARs

664. Signifor - pasireotide

attempts), irradiation (fractionated external beam radiotherapy or stereotactic radiosurgery) of the pituitary or bilateral adrenalectomy are the remaining non-medical treatment options. Available medical options generally fill a short-term, palliative role and are rarely used alone as long- term therapy. The use of these drugs is based on limited data; their safety and efficacy profiles are not well established. In the following section, the efficacy and safety of commonly used medications (...) with an increased risk of side effects. Metyrapone is a pyridine which acts by blocking 11 ß-hydroxilase, thus inhibiting aldosterone biosynthesis. There are no large prospective studies on the efficacy of metyrapone as monotherapy. Treatment with metyrapone in combination with radiation therapy or other drugs normalised plasma cortisol in up to 74% of patients with Cushing’s disease and Cushing’s syndrome. Reduction of cortisol levels may induce an increase in pituitary ACTH secretion. Therefore, like

2012 European Medicines Agency - EPARs

665. Kalydeco - ivacaftor

Patient Registry 2009; Colombo 2011). It is acknowledged that patients with CF represent a high unmet medical need for effective therapies. About the product Ivacaftor, also referred to as VX-770, is an orally bioavailable small molecule that claims to provide a new therapeutic approach to the treatment of CF by targeting the pathophysiology of cystic fibrosis – the dysfunctional CFTR protein. Ivacaftor represents a proposed new class of drugs, CFTR modulators, which restore the function of the CFTR (...) ; ? The study package intended for submission is expected to provide a reasonable basis for the benefit risk assessment, the endpoints used in pivotal studies appear adequate and able to reflect a clinically meaningful effect; ? The preliminary review of the available data suggests that the effect on pulmonary function parameters might be of clinical interest. Furthermore, treatment with ivacaftor might potentially decrease the need for other medical therapies; ? Overall, the medicinal product is considered

2012 European Medicines Agency - EPARs

666. NexoBrid - concentrate of proteolytic enzymes enriched in bromelain

Dalton DF Diafiltration DIN Deutsches Institut für Normierung German Industrial Standard DP Drug Product DS Drug Substance EDTA-Na2 Ethylenediaminetetraacetic acid Disodium salt EC European Commission EP European Pharmacopoeia g gram(s) GACP good agricultural and collection practice GMP Good Manufacturing Practice HACCP Hazard analysis and critical control point HAV Hepatitis-A virus HVAC Heating, Ventilating, and Air Conditioning HCl Hydrochloric Acid HMPC Committee on Herbal Medicinal Products HPLC (...) . The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 17 December 2009. NexoBrid was designated as an orphan medicinal product EU/3/02/107 on 30 July 2002. NexoBrid was designated as an orphan medicinal product in the following indication: Treatment of partial deep dermal and full thickness burns. The applicant applied for the following indication: Timely, selective removal of eschar in patients with deep partial- and/or full-thickness burns. The legal basis for this application

2012 European Medicines Agency - EPARs

667. Esmya - ulipristal

www.ema.europa.eu © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. Product information Name of the medicinal product: Esmya Applicant: PregLem France SAS. 32, route de l’Eglise F-74140 Massongy France Active substance: ulipristal acetate International Non-proprietary Name: ulipristal Pharmaco-therapeutic group (ATC Code): Uterine myoma Therapeutic indication(s): Ulipristal acetate is indicated for pre-operative treatment of moderate to severe symptoms of uterine (...) fibroids in adult women of reproductive age. The duration of treatment is limited to 3 months (see section 4.4) Pharmaceutical form: Tablet Strength: 5 mg Route of administration: Oral use Packaging: PVC/PE/PVDC/Alu blisters Package size: 28 tablets Esmya CHMP assessment report Rev06.11 Page 2/106 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 Information on Paediatric requirements 7 Information relating to orphan market exclusivity 7 Applicant’s request

2012 European Medicines Agency - EPARs

668. Alogliptin and alogliptin/pioglitazone

Alogliptin and alogliptin/pioglitazone CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022426Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Complete Response Application Number(s) 22-271 and 22-426 Priority or Standard Standard Submit Date(s) 7-26-12 Received Date(s) 7-26-12 PDUFA Goal Date 1-26-13 Division / Office DMEP/ODEII/OND Reviewer Name(s) Valerie S.W. Pratt, M.D. Review Completion Date 01-17-13 Established Name Alogliptin and alogliptin/pioglitazone FDC (...) Congestive heart failure CI Confidence interval Cmax Maximum concentration CMC Chemistry Manufacturing and Controls CR Complete response Cr Creatinine CrCl Creatinine clearance CRF Case report form CV Cardiovascular DBP Diastolic blood pressure DDI Drug-drug interaction DILI Drug-induced liver injury DMC Data monitoring committee DMEP Division of Metabolism and Endocrinology Products DMEPA Division of Medication Error Prevention and Analysis DMF Drug master file DMPP Division of Medical Policy Programs

2012 FDA - Drug Approval Package

669. Workplace Disability Management Programs Promoting Return to Work: A Systematic Review Full Text available with Trip Pro

to the present injury or illness and the cultural, legal and structural context of the labor market ( ; ; ; ). DM practices aimed at RTW involve dynamic interactions between the individual's health condition and contextual factors such as the employer, healthcare and social/compensation systems ( ; ; ; ; ; ; ). The recognition of the impact of social and contextual factors on RTW is also referred to as a paradigm shift from disease prevention and treatment to disability prevention and management ( ; ). Given (...) consequences resulting in great societal impact ( ; ). Long‐term sickness absence often represents a substantial individual life event ( ), where the duration of absence due to injury or illness increases the future risk of receiving disability pension and permanent exclusion from the labor market ( ; ). At the employer level long‐term sickness absence may lead to lower productivity and quality, higher employee turnover and reduction in job satisfaction due to the added workload placed on other employees

2012 Campbell Collaboration

670. Behavioural and cognitive?behavioural group?based parenting programmes for early?onset conduct problems in children aged 3 to 12 years Full Text available with Trip Pro

Disorder (ADHD) ( ; ). The prognosis for early‐onset conduct problems (when compared with onset in adolescence) is poor and the negative outcomes in adolescence and adulthood may include antisocial and criminal behaviour ( ; ); psychiatric disorders; drug and alcohol abuse; higher rates of hospitalisation and mortality; higher rates of school drop‐out and lower levels of educational attainment; greater unemployment; family breakdown; and intergenerational transmission of conduct problems to children (...) see Characteristics of included studies for further details about components of each intervention. Different behavioural and cognitive‐behavioural parenting programmes also vary in the extent to which they appear to be effective with families who are most at risk or children with the most severe problems ( ; ). 1.3 HOW THE INTERVENTION MIGHT WORK Behavioural and cognitive‐behavioural interventions incorporate social learning principles and techniques from cognitive therapy alongside principles

2012 Campbell Collaboration

671. Pre-procedure pregnancy checking for under-16s

Significant numbers of children and young people (C&YP) undergo elective and emergency surgical, radiological, anaesthetic and some medical procedures in the United Kingdom each year. If the patient is pregnant there is a small but recognised risk to the patient and her pregnancy/fetus and potentially a need to modify the technique or delay the procedure. A number of authorities, including NICE and the Health Protection Agency, stipulate that pregnancy status must be ascertained before a procedure (...) documentation in the medical notes of the clinical and safeguarding actions taken in light of the result. Suggested minimum documentation in the integrated care plan: For female patients of child-bearing age: Any possibility of pregnancy on questioning? Yes/No/Unknown Consent given for pregnancy test? Yes/No/N/A Result of urine test? Negative/Positive Action taken: Proceed/Postpone/Referral Clinical decision that questioning/testing not appropriate: 5. Clinical emergencies and long-term conditions 5.1 When

2012 Royal College of Paediatrics and Child Health

672. Interventions to reduce the prevalence of female genital mutilation/cutting in African countries Full Text available with Trip Pro

practice that involves the partial or total removal or other injury to the female genital organs for non‐medical reasons (WHO, 2008). The WHO's (1997) current classification describes four types of FGM/C: Type 1 (clitoridectomy) involves partial or total removal of the clitoris and/or the prepuce. Type 2 (excision) involves partial or total removal of the clitoris and the labia minora, with or without excision of the labia majora. Type 3 (infibulations) involves narrowing of the vaginal orifice (...) with creation of a covering seal by cutting and appositioning the labia minora and/or the labia majora, with or without excision of the clitoris. Infibulation is considered the most invasive type of FGM/C. Defibulation, opening of the covering seal, is often necessary prior to childbirth. Reinfibulation refers to the recreation of an infibulation after defibulation. Type 4 (other), involves all other harmful procedures to the female genitalia for non‐medical purposes, for example: pricking, piercing

2012 Campbell Collaboration

673. Priority-setting methods to inform prioritisation

. It was current at the time of production (but not necessarily at the time of publication). It is reproduced for general information and third parties rely upon it at their own risk. Contents EXECUTIVE SUMMARY 5 Key criteria in priority setting frameworks 5 Main approaches to priority setting emerging from the literature 7 Recommended approach 9 Survey with researchers 10 Other questions addressed in the review 10 1 Background, introduction and methods used in selecting sources 11 The method used for search (...) ; some based on principles (or values) which might include fairness, accountability, etc.; and others focused on what they seek to achieve i.e. objectives such as health maximisation. Such principles can be more or less acceptable to those in the system and to those the system serves • Having the capacity to be understood and acted upon by clinicians in health services and networks: if clinicians cannot see the sense in the priority setting approach, they may well baulk at acting upon it. Highly

2012 Sax Institute Evidence Check

674. British HIV Association guidelines for the management of HIV infection in pregnant women

medications consider the addition of double-dose tenofovir (to the treatment described in 5.4.2) to further load the baby. Grading: 2C 5.4.6 Women presenting in labour/with rupture of membranes (ROM)/requiring delivery without a documented HIV result must be recommended to have an urgent HIV test. A reactive/positive result must be acted upon immediately with initiation of the interventions for prevention of MTCT (PMTCT) without waiting for further/formal serological con?rmation. Grading: 1D 5.5 Elite (...) HIV Medicine (2012), 13 (Suppl. 2), 87–1571.0 Scope and purpose The overall purpose of these guidelines is to provide guid- ance on best clinical practice in the treatment and man- agement of human immunode?ciency virus (HIV)-positive pregnant women in the UK. The scope includes guidance on the use of antiretroviral therapy (ART) both to prevent HIV mother-to-child transmission (MTCT) and for the welfare of the mother herself, guidance on mode of deliv- ery and recommendations in speci?c patient

2012 The Children's HIV Association

675. Acute Myocardial Infarction in patients presenting with ST-segment elevation

antiplatelet therapy DES drug-eluting stent DIGAMI Diabetes, Insulin Glucose Infusion in Acute Myocardial Infarction EAPCI European Association of Percutaneous Car- diovascular Interventions ECG electrocardiogram EMS emergency medical system EPHESUS Eplerenone Post-AMI Heart failure Ef?cacy and SUrvival Study ESC European Society of Cardiology ExTRACT-TIMI 25 Enoxaparin and Thrombolysis Reperfusion for ACute myocardial infarction Treatment— Thrombolysis In Myocardial Infarction 25 FINESSE Facilitated (...) which justi?es continuous efforts to improve quality of care, adherence to guidelines and research. 3. Emergency care 3.1 Initial diagnosis Management—including both diagnosis and treatment—of AMI starts at the point of ?rst medical contact (FMC), de?ned as the point at which the patient is either initially assessed by a paramedic or physician or other medical personnel in the pre-hospital setting, or the patient arrives at the hospital emergency department— and therefore often in the outpatient

2012 European Society of Cardiology

676. Acute and Chronic Heart Failure

. Persistence of symptoms despite treatment usually indicates the need for add- itional therapy, and worsening of symptoms is a serious develop- ment (placing the patient at risk of urgent hospital admission and death) and merits prompt medical attention. 3.6.2 General diagnostic tests in patients with suspected heart failure In view of the dif?culty in grading the evidence for diagnostic tests, all diagnostic recommendations have been given an arbitrary evidence level of C. 3.6.3 Essential initial (...) & Rehabilitation (EACPR), European Association of Echocardiography (EAE), European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) Working Groups: Acute Cardiac Care, Cardiovascular Pharmacology and Drug Therapy, Cardiovascular Surgery, Grown-up Congenital Heart Disease, Hypertension and the Heart, Myocardial and Pericardial Diseases, Pulmonary Circulation and Right Ventricular Function, Thrombosis, Valvular Heart Disease Councils: Cardiovascular

2012 European Society of Cardiology

677. Multiple pregnancy: antenatal care for twin and triplet pregnancies

and treatment, in partnership with their healthcare professionals. If women do not have the capacity to make decisions, healthcare professionals should follow the the Department of Health's advice on consent and the code of practice that accompanies the Mental Capacity Act. In Wales, healthcare professionals should follow advice on consent from the Welsh Government. Good communication between healthcare professionals and women is essential. It should be supported by evidence-based written information (...) /terms-and- conditions#notice-of-rights). Page 2 of 42Contents Contents Overview 5 Who is it for? 5 Introduction 6 Woman-centred care 8 Key priorities for implementation 9 1 Guidance 12 1.1 Determining gestational age and chorionicity 12 1.2 General care 14 1.3 Fetal complications 17 1.4 Maternal complications 20 1.5 Preterm birth 20 1.6 Indications for referral to a tertiary level fetal medicine centre 21 1.7 Timing of birth 22 2 Notes on the scope of the guidance 24 3 Implementation 25 4 Research

2011 National Institute for Health and Clinical Excellence - Clinical Guidelines

679. Evidence-based guidelines for treating bipolar disorder

of medication is integrated with a coherent approach to psychoeducation and behaviour change. Keywords Bipolar disorder, treatment, evidence-based guidelines, antipsychotics, antidepressants, mood stabilizers, lithium, psychoeducation, cognitive behaviour therapy 1 University Department of Psychiatry, Warneford Hospital, Oxford, UK 2 Greater Manchester West Mental Health NHS Foundation Trust, Eccles, Manchester, UK 3 Institute of Neuroscience, Newcastle University, UK and Northumberland Tyne and Wear NHS (...) . Such studies are crucial in supporting our recom- mendations for the long-term use of drugs in bipolar disorder.Goodwin et al. 499 Psychotherapy trials Psychotherapy trials pose difficulties for evidence-based prac- tice that have not been sufficiently recognized. The choice of a fair comparison treatment is much more challenging than for medicines. It is often simply ducked by using a poorly specified ‘treatment as usual’ condition. While this may be defensible in a pragmatic study of effectiveness

2016 British Association for Psychopharmacology

680. IDegLira HIGH Trial

2021 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: IDegLira Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks. Drug: IDegLira Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily (...) Description Go to Brief Summary: Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c >9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Thus, there is a critical need for a simpler treatment regimen that could overcome these limitations. IDegLira, a fixed-ratio combination (FRC) therapy consisting of insulin degludec and liraglutide

2018 Clinical Trials

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