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Cushing Response

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281. Corticosteroids - topical (skin), nose, and eyes: Scenario: Topical treatment

, instead of treating flares as they arise, in people with frequent flares. Review people receiving intermittent treatment every 3–6 months depending on the potency and site of application. Once a clinical response has been seen, long-term topical corticosteroid treatment should be gradually in a stepwise manner. For more information on managing eczema and psoriasis, see the CKS topics on and . Basis for recommendation These recommendations are based on the National Institute for Health and Care (...) be applied? A thin layer of topical corticosteroid should be applied once or twice daily, adjusting the potency to control symptoms. For many conditions, once daily application is usually sufficient. Increase to twice daily application only if the condition does not respond adequately. Avoid the use of the phrase 'use sparingly' to avoid undertreatment. Topical corticosteroids should typically be used in bursts of 3–7 days in order to achieve control. Once a clinical response is seen, the corticosteroid

2018 NICE Clinical Knowledge Summaries

282. Corticosteroids - oral: Scenario: Corticosteroids

that an appropriate protective immune response may occur [ ]. What contraindications and cautions are associated with oral corticosteroids? Oral corticosteroids are contraindicated in: People with acute infections uncontrolled by appropriate antimicrobial therapy — they may mask the symptoms of infection. Oral corticosteroids should be used with caution in people with: Hepatic impairment — plasma concentrations of oral corticosteroids may be increased in hepatic impairment. Psychoses or severe affective disorders (...) . Cerebrovascular — benign intracranial hypertension. Endocrine — adrenal suppression, diabetes mellitus (new onset or worsening of blood glucose control in existing diabetes mellitus), Cushing's syndrome (this is usually reversible on withdrawal of treatment). Gastrointestinal — peptic ulceration with perforation and haemorrhage, dyspepsia, abdominal distension, and oesophageal ulceration; especially in . Immunological — immunosuppression, increased susceptibility to infection, aggravation of existing

2018 NICE Clinical Knowledge Summaries

283. Recovery: care of the child/young person

spontaneous movement or deterioration in reflexive posturing purposeful movement deteriorates decorticate posturing, and then decerebrate posturing, and then flaccid response to pain 4. Cushing’s triad (hypertension, bradycardia, apnoea) may occur only as a late sign ( ). Routinely measure intracranial pressure on patients who have monitoring devices in situ ( ). Immediately report to the surgeon and anaesthetist any fluctuations in intracranial pressure outside of normal parameters ( ) ( ). Liaise (...) ( ). Neurological assessment Evaluate the patient’s alertness and responsiveness to the environment ( ). Perform a rapid but thorough neurological assessment for all patients who have undergone neurological/neurosurgical procedures ( ). This must incorporate an assessment of eye opening, verbal responsiveness, motor function and reflexes, and pupil size and response to light, as per GOSH clinical procedure guideline. Continue neurological observations at 10 minute intervals alongside the recording of vital

2015 Publication 1593

284. Clinical Practice Guidelines on Obesity

and patterns of care evolve. The contents of this publication are guidelines to clinical practice, based on the best available evidence at the time of development. Adherence to these guidelines may not ensure a successful outcome in every case. These guidelines should neither be construed as including all proper methods of care, nor exclude other acceptable methods of care. Each physician is ultimately responsible for the management of his/her unique patient, in the light of the clinical data presented (...) • Fasting plasma glucose • Alanine transaminase / aspartate transaminase • ECG (if > 50 years)3 Assessment for secondary causes: • Thyroid function tests: Thyroid stimulating hormone / free thyroxine • Cushing’s syndrome: Screen only if clinically suspected • Hypogonadism: Screen only if clinically suspected BMI: body mass index; ECG: electrocardiography; HDL: high-density lipoprotein; LDL: low-density lipoprotein GPP C Patient motivation – an important prerequisite in weight loss management – should

2016 Ministry of Health, Singapore

285. Diagnosis of Right Lower Quadrant Pain and Suspected Acute Appendicitis

Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00012-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. None of the investigators have (...) number is CRD42013006480. AHRQ TOO and External Stakeholder Input A panel of Key Informants, including patients and other stakeholders, gave input on the Key Questions to be examined. These Key Questions were posted on AHRQ’s Effective Health Care Web site for public comment and revised in response to comments. A Technical Expert Panel, including representatives of professional societies and experts in the diagnosis and treatment of RLQ abdominal pain and appendicitis, provided input to help further

2016 Effective Health Care Program (AHRQ)

286. Hypertensive disorders of pregnancy

be appropriate. This guideline does not address all elements of standard practice and accepts that individual clinicians are responsible for: • Providing care within the context of locally available resources, expertise, and scope of practice • Supporting consumer rights and informed decision making in partnership with healthcare practitioners including the right to decline intervention or ongoing management • Advising consumers of their choices in an environment that is culturally appropriate and which (...) enables comfortable and confidential discussion. This includes the use of interpreter services where necessary • Ensuring informed consent is obtained prior to delivering care • Meeting all legislative requirements and professional standards • Applying standard precautions, and additional precautions as necessary, when delivering care • Documenting all care in accordance with mandatory and local requirements Queensland Health disclaims, to the maximum extent permitted by law, all responsibility

2016 Queensland Health

287. Reversal of a Blunted Follicle-Stimulating Hormone by Chemotherapy in an Inhibin B–Secreting Adrenocortical Carcinoma Full Text available with Trip Pro

Reversal of a Blunted Follicle-Stimulating Hormone by Chemotherapy in an Inhibin B–Secreting Adrenocortical Carcinoma Adrenocortical carcinomas (ACCs) are revealed in 60% of cases by steroid hypersecretion. Alternatively, it is uncommon to observe a paraneoplastic syndrome due to a peptide oversecretion.We describe a 60-year-old man with a right adrenal mass. Hormonal evaluation showed an ACTH-independent Cushing syndrome. Surprisingly, follicle-stimulating hormone (FSH) levels were (...) the response to chemotherapy and mitotane was associated with a normalization of inhibin B secretion, allowing the reversal of the blunted FSH secretion. Inhibin B should be measured in case of suppressed FSH levels despite normal luteinizing hormone levels and may be considered a tumoral marker in some ACCs, even during treatment follow-up.

2017 Journal of the Endocrine Society

288. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient

, and dietitians was jointly convened by the 2 societies. Literature searches were then performed using keywords ( critically ill , critical care , intensive care , nutrition , enteral , parenteral , tube feeding , and those related to assigned topics, such as pancreatitis , sepsis , etc) to evaluate the quality of evidence supporting a response to those questions, which were then used to derive a subsequent treatment recommendation. The literature search included MEDLINE, PubMed, Cochrane Database of Systemic (...) Reviews, the National Guideline Clearinghouse, and an Internet search using the Google search engine for scholarly articles through an end date of December 31, 2013 (including ePub publications). While preference was given to RCTs, other forms of resource material were used to support the response, including nonrandomized cohort trials, prospective observational studies, and retrospective case series. Use of publications was limited to full‐text articles available in English on adult humans. For all

2016 American Society for Parenteral and Enteral Nutrition

289. Practice Guidelines for the Diagnosis and Management of Aspergillosis Full Text available with Trip Pro

is not recommended ( strong recommendation; moderate-quality evidence) . Contrast is recommended when a nodule or a mass is close to a large vessel ( strong recommendation; moderate-quality evidence) . 15. We suggest a follow-up chest CT scan to assess the response of IPA to treatment after a minimum of 2 weeks of treatment; earlier assessment is indicated if the patient clinically deteriorates ( weak recommendation; low-quality evidence). When a nodule is close to a large vessel, more frequent monitoring may (...) with a nonoverlapping side-effect profile (strong recommendation; low-quality evidence) . 42. For salvage therapy, agents include lipid formulations of AmB, micafungin, caspofungin, posaconazole, or itraconazole. The use of a triazole as salvage therapy should take into account prior antifungal therapy, host factors, pharmacokinetic considerations, and possible antifungal resistance (strong recommendation; moderate-quality evidence) . How Can Biomarkers Be Used to Assess Patient Response to Therapy? Recommendations

2016 Infectious Diseases Society of America

290. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity

negatively affects an individual patient’s health. In response to this emergent concept from the CCO, the AACE proposed an “Advanced Framework for a New Diagnosis of Obesity.” This document features an anthro- pometric component that is the measure of adiposity (i.e., BMI) and a clinical component that describes the presence and severity of weight-related complications (15 [EL 4; NE]). Given the multiple meanings and perspectives asso- ciated with the term “obesity” in our society, there was also (...) recommendations based on the evidence in response to each question. Clinical questions are labeled “Q,” and recommendations are labeled “R.” Formulation of Recommendations The task force discussed and critiqued each of the evidence reviews and recommendations, which were then revised for consensus approval. The evidence ratings were used to grade the scientific strength of the recommenda - tions. Recommendations (numerically labeled “R1, R2,” etc.) are based on strength-of-evidence, indexed to the BEL, which

2016 American Association of Clinical Endocrinologists

291. Screening and Management of Lipids

sequestrants, protease inhibitors, retinoic acid, anabolic steroids, sirolimus, raloxifene, tamoxifen, beta blockers (not carvedilol), thiazides Diseases Biliary obstruction, nephrotic syndrome Nephrotic syndrome, chronic renal failure, lipodystrophies, Cushing's syndrome Disorders and altered states of metabolism Hypothyroidism, obesity, pregnancy* Diabetes (poorly controlled), hypothyroidism, obesity, inactivity; pregnancy* * Cholesterol and triglycerides rise progressively throughout pregnancy (...) pattern and USDA food pattern were cited as examples of dietary patterns which are in line with current recommendations. A trial of diet should not delay statin therapy in secondary prevention patients. The degree of response to various dietary interventions including soluble fiber, soy, and plant stanols correlates highly with the amount consumed and baseline LDL-C levels. Prescribed diets should not be restrictive, but instead emphasize what should be eaten rather than what should not be eaten

2016 University of Michigan Health System

292. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumours Full Text available with Trip Pro

autonomous cortisol secretion, formerly called ‘subclinical’ Cushing’s syndrome?; (C) Who should have surgical treatment and how should it be performed?; (D) What follow-up is indicated if the adrenal incidentaloma is not surgically removed? Selected recommendations: (i) At the time of initial detection of an adrenal mass establishing whether the mass is benign or malignant is an important aim to avoid cumbersome and expensive follow-up imaging in those with benign disease. (ii) To exclude cortisol (...) excess, a 1mg overnight dexamethasone suppression test should be performed (applying a cut-off value of serum cortisol ≤50nmol/L (1.8µg/dL)). (iii) For patients without clinical signs of overt Cushing’s syndrome but serum cortisol levels post 1mg dexamethasone >138nmol/L (>5µg/dL), we propose the term ‘autonomous cortisol secretion’. (iv) All patients with ‘(possible) autonomous cortisol’ secretion should be screened for hypertension and type 2 diabetes mellitus, to ensure these are appropriately

2016 European Society of Endocrinology

293. CRACKCast E038 – Pediatric Trauma

with rupture of bridging veins. most common in kids <2 yrs. of age may be chronic in the child with “shaken baby syndrome” or NAT vague: vomiting failure to thrive, altered LOC, seizures. need fundoscopic exam to rule out retinal hemorrhage pathognomonic of NAT (non-accidental trauma) 12) Describe the management of elevated ICP Diagnostic strategies: serial exams are key absence of focal findings doesn’t rule out injury papilledema requires days to develop cushing’s response is ominous monro-kellie (...) for inotropy: blood pressure mostly dependent on chronotropy and SVR tachycardia and slow cap. refill are warning signs of impending decompensation!** 2) List 8 airway differences between pediatrics and adults with their relevant implications Differences Implications Physiologic Increased vagal response to laryngoscopy Bradycardia – have atropine on hand! Anatomic Larger tongue #1 cause of airway obstruction; need better head positioning +/- OPA/NPA Larger adenoidal tissues Nasotracheal intubation

2016 CandiEM

294. CRACKCast E041 – Head Injury

= compressed oculomotor nerve CONTRALATERAL: (+) Babinski’s sign (upward going big toe and outward fanning of the other toes) Contra-lateral hemiparesis, then may progress to bilateral decerebrate posturing As the brainstem becomes compressed: agitation > restlessness > confusion > coma > cushing’s reflex > cardiac collapse Describe the presentation of central herniation. Signs: May be subtle LOC changes → bilateral motor weakness → pinpoint pupils → increased muscle tone and bilateral babinski’s (...) hypotension and hypoxia There is a risk-benefit debate in the literature about the safety of out of hospital intubation – requires good protocols and training to do safely Neuro exam Treatment of scalp bleeding Sedatives/paralytics for agitated patients Notes: 10% of TBI’s in the ED are severe 25% of these need neuroSx inital GCS or CT does NOT reliably predict prognosis Depends on: Age comorbidities initial motor activity pupil response secondary insults 35% mortality rate Emergency department care

2016 CandiEM

295. Mental Pathologies at the Root of Modern Medical Training: Lessons from the Life of Professor William Stewart Halsted

of minds at Hopkins to meet or exceed him, and when students were called on for an answer, an incorrect response could be met with biting sarcasm or open ridicule. From his students he culled candidates for his surgical residency program—the first in the world and a highly influential model for the academic surgery to follow, with greats such as Harvey Cushing directly indebted to Halsted’s mentorship. 10 As the longest witness to Halsted’s academic trials, surgical resident John M.T. Finney sums up (...) responsibilities. Spoken or unspoken, this fear is a corroding thread that innervates the medical education experience. It has ruined lives, pushing medical students, residents, and fellows 1,2,3 Male physicians commit suicide at twice the national average, . 4 Perhaps this is something we carry into medicine, generation after generation of sensitive souls, trying to help others in ways we can’t help ourselves. Poetic as this may sound, we have evidence to believe it isn’t true. A survey of students prior

2016 Clinical Correlations

296. Neurological observations

Ormond Street Hospital for Children is a nationally accepted adaptation of the Glasgow Coma Scale (GCS), devised by and the Adelaide Paediatric Coma Scale ( ). Incorporated into the chart are a pain score and a record of significant events (see ). The GCS demonstrates level of consciousness by assessing a patient’s ability to perform three activities: eye opening verbal response motor response Each response is assigned a score, and the three scores, added together, give a total score ranging from 3 (...) , it is important that this is recorded by marking a 'C' in the appropriate space on the assessment tool ( ). Scores for verbal response This part of the assessment is scored from 1-5 and provides a description for both the infant/preverbal child and the verbal CYP ( ) Score 5 infant/preverbal child - smiling or contented infant who may coo or babble orientated, verbal CYP ( ). Involve the family to use appropriate familiar words to encourage the child to verbalise ( ). Score 4 infant/preverbal child - crying

2014 Publication 1593

297. Cometriq - cabozantinib

aspects 30 2.4.1. Introduction 30 2.4.2. Pharmacokinetics 31 2.4.3. Pharmacodynamics 33 2.4.4. Discussion on clinical pharmacology 39 2.4.5. Conclusions on clinical pharmacology 42 2.5. Clinical efficacy 42 2.5.1. Dose response study 42 2.5.2. Main study 43 2.5.3. Discussion on clinical efficacy 66 2.5.4. Conclusions on the clinical efficacy 68 2.6. Clinical safety 69 2.6.1. Discussion on clinical safety 85 2.6.2. Conclusions on the clinical safety 89 2.7. Pharmacovigilance 89 2.8. Risk Management (...) on 29 November 2012. 1.2. Manufacturers Manufacturer responsible for batch release Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Park Westhoughton Bolton, Lancashire BL5 3XX UK United Kingdom 1.3. Steps taken for the assessment of the product The Rapporteur and Co-Rapporteur appointed by the CHMP and the evaluation teams were: Rapporteur: Pieter de Graeff Co-Rapporteur: Ingunn Hagen Westgaard • The application was received by the EMA on 29 October 2012. • The procedure started

2014 European Medicines Agency - EPARs

298. Budesonide/Formoterol Teva Pharma B.V. (budesonide / formoterol)

Advice from the CHMP on 24/9/2009, 6/11/2009, 8/12/2009, 9/4/2010, 22/4/2010, 18/11/2010, 22/9/2011 and 16/2/2012. The Scientific Advice pertained to quality and clinical aspects of the dossier. Licensing status The product was not licensed in any country at the time of submission of the application. 1.2. Manufacturers Manufacturer(s) responsible for batch release Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park Cork Road Waterford Ireland Teva (...) to the applicant on 25 July 2014. • The applicant submitted the responses to the CHMP consolidated List of Questions on 22 August 2014. • The Rapporteur circulated the Assessment Report on the applicant’s responses to the List of Questions to all CHMP members on 11 September 2014. • During the meeting on 25 September 2014, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, issued a positive opinion for granting a Marketing Authorisation to Budesonide

2014 European Medicines Agency - EPARs

299. Ketoconazole HRA

2.8. Risk Management Plan 79 2.9. Product information 84 3. Benefit-Risk Balance 85 Benefits 85 Risks 86 Benefit-risk balance 88 4. Recommendations 89 Ketoconazole HRA Assessment report EMA/CHMP/534845/2014 Page 3/115 List of abbreviations ACTH Adrenocorticotrophin Hormone AE Adverse events AGT Aminoglutethimide AI Adrenal insufficiency ALT Alanine transaminase AP Alkaline phosphatase AST Aspartate transaminase AUC Area under the curve b.i.d Twice a day CD Cushing’s disease CRH Corticotropin (...) Releasing Hormone CS Cushing’s Syndrome D Day DDD Defined Daily Dose DHEA Dehydroepiandrosterone DHEAS Dehydroepiandrosterone sulfate DOC Deoxycorticosterone EAS Ectopic ACTH Syndrome EC European Commission EIA Enzyme immunoassay EU European Union F Female GCP Good Clinical Practice HR Hour KC Ketoconazole M Male MET Metyrapone MTH Month NAH Nodular adrenal/adrenocortical hyperplasia NC Not controlled NIH National Institute of Health RIA Radio immunoassay SD Standard deviation SMR Standard mortality

2014 European Medicines Agency - EPARs

300. DuoResp Spiromax - budesonide / formoterol

. In the isolated guinea pig lung, both formoterol and salbutamol exhibited dose-dependent inhibition of antigen-induced histamine release. However, in the isolated rat mesenterium these two drugs showed only partial inhibition of antigen-induced mast cell degranulation. Neither formoterol nor salbutamol affected the hapten-specific IgE antibody response in female mice (Tomioka, 1981). Formoterol was also shown to inhibit histamine-induced plasma albumin extravasation in anaesthetised guinea pigs and allergen (...) response to provocation. These effects provide evidence that the combination of budesonide and formoterol delivers a greater benefit compared to either drug administered alone (FDA, 2006). Furthermore, formoterol, when added to budesonide in human lung fibroblasts exerted an additive effect of the inhibition of IL-1ß (Sharafkhaneh, 2002). In mouse tracheal smooth muscle, ß2-receptors mRNA was not affected by cytokines (IL-1 ß at 10 ng/mL) but increased with budesonide (1 µM) exposure. However

2014 European Medicines Agency - EPARs

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