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Cushing Response

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281. 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

282. 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

283. 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

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. 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

286. 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

287. 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

288. A Practice Guideline from the American College of Medical Genetics and Genomics and the National Society of Genetic Counselors: Referral Indications for Cancer Predisposition Assessment

- cer. The major gene(s) responsible for hereditary mixed polypo- sis syndrome have not been identified; however, some cases are caused by mutations in the BMPR1A gene. 88–90 Also, a founder mutation involving the GREM1 gene was identified in Ashkenazi Jewish patients with hereditary mixed polyposis syndrome. 91 Referral should be considered for any individual with a per- sonal history of or first-degree relative with =10 colorectal pol- yps with mixed histology. Hereditary papillary RCC (OMiM (...) spontaneous pneumothorax. Curr Opin Pulm Med 2006;12:268–272. 18. Bertherat J, Horvath A, Groussin L, et al. Mutations in regulatory subunit type 1A of cyclic adenosine 5’-monophosphate-dependent protein kinase (PRKAR1A): phenotype analysis in 353 patients and 80 different genotypes. J Clin Endocrinol Metab 2009;94:2085–2091. 19. Groussin L, Jullian E, Perlemoine K, et al. Mutations of the PRKAR1A gene in Cushing’ s syndrome due to sporadic primary pigmented nodular adrenocortical disease. J Clin

2015 American College of Medical Genetics and Genomics

289. American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

in the previous 6 months, health care personnel). 35 the panel con- ditionally recommended that in RA patients ages$50 years, the herpes zoster vaccine should be given before the patient receives biologic therapy or tofacitinib for their RA. 45 response to certain killed vaccines may be reduced after rituximab therapy. 55 the panel conditionally recommended giving the herpes zoster vaccine before the patient receives biologic therapy or tofacitinib for their RA in both early or established RA patients ages$50 (...) of killed vac- cines in adults and no signi?cant concerns of harm in RA patients receiving biologics, as per the gener- al guidance from the CDC. Clinicians should con- sult the CDC recommendations for killed vaccines (136–140). Responses to some killed vaccines may be reduced after rituximab therapy (141) and possi- bly after MTX therapy. Whenever possible, vac- cines should be given prior to receiving therapy. In addition to these recommendations, the Voting Panel endorsed the vaccination

2015 American College of Rheumatology

290. Medical eligibility criteria for contraceptive use

that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility (...) ) No serious inconsistency (direction consistent; variability in magnitude) No serious imprecision Serious indirectness (not women using CHC vs not using CHC) Duration-response effect in first 6 weeks, first 1–3 weeks associated with highest risk; a weeks 0–6 associated with higher risk than after week 7 b Low Any VTE (2 studies): rate ratio 21.5 (CI not available) and 22 (95% CI 18–27) and OR 84 (95% CI 32–223) and 12 (95% CI 7.9–18.6) DVT (1 study): incidence ratio 15 (95% CI 13–18) Pulmonary embolism (1

2015 World Health Organisation Guidelines

291. Male Sexual Dysfunction

and 2 diabetes mellitus - Chronic renal failure - Polyneuropathy - Surgery (major surgery of pelvis/retroperitoneum, RP , colorectal surgery, etc.) Surgery of the urethra (urethral stricture urethroplasty, etc) Anatomical or structural - Hypospadias, epispedias - Micropenis - Peyronie’s disease Hormonal - Hypogonadism - Hyperprolactinemia - Hyper- and hypothyroidism - Hyper- and hypocortisolism (Cushing’s disease, etc.) Panhypopituitarism and multiple endocrine disorders Drug-induced (...) of the penis that lasts for > 10 min [61]. 3A.3.6.2 Intracavernous injection test The intracavernous injection test gives limited information about vascular status. A positive test is a rigid erectile response (unable to bend the penis) that appears within 10 min after the intracavernous injection and lasts for 30 min [62]. Overall, the test is inconclusive as a diagnostic procedure and a duplex Doppler study of the penis should be requested, if clinically warranted. 3A.3.6.3 Duplex ultrasound of the penis

2015 European Association of Urology

292. Clinical Practice Guideline on the Management of Depression in Adults

and DSM provide a set of agreed criteria to rely on. C Due to the existence of different factors that may affect the progress, course and severity of depression, it is recommended to evaluate the following areas: – Features of the episode: duration, number and intensity of symptoms, comorbidity. – Psychosocial assessment (social support and interpersonal relationships). – Degree of associated dysfunction and/or disabilities. – Risk of suicide. – Response to previous treatment. C It is recommended (...) . If the response is positive, an appropriate psychopathological assessment is recommended. Care models B The management of depression in adults should be performed as a stepped care and collaboration model between primary care and mental health, so that interventions and treatments are tailored to the status and evolution of the patient. General treatment recommendations v The treatment of depression in adults should be comprehensive and cover all psychotherapeutic, psychosocial and pharmacological

2015 GuiaSalud

293. Acute Pain Management: Scientific Evidence

Institute of Medicine defined patient-centred care as ‘‘care that is respectful of and responsive to individual patient preferences, needs and values’’ (National Research Council 2001; Meissner 2015 ). This reminds us that despite the best available evidence, patient values and involvement should always guide all our clinical decisions (National Research Council 2001; Meissner 2015 ). These remain exciting times in acute pain medicine. This fourth edition has emphasised the role played by acute pain (...) management as a vital component of perioperative and post- traumatic care. Our responsibility as anaesthetists and specialist pain medicine physicians is to understand and modify the pathogenic mechanisms of the undesirable responses to surgical and traumatic injury ( Kehlet, in press). Only in this way will we optimise acute pain management and boost recovery and improve safety. We are indebted to Professor Schug and his team for providing us with an update of the scientific evidence. The challenge

2015 Clinical Practice Guidelines Portal

294. 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

295. 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

296. 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

297. BiResp Spiromax (budesonide / formoterol fumarate dihydrate)

exhibited dose-dependent inhibition of antigen-induced histamine release. However, in the isolated rat mesenterium these two drugs showed only partial inhibition of CHMP assessment report EMA/CHMP/175684/2014 Page 23/106 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

298. 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

299. Management of Osteoporosis

as scientific knowledge advances and patterns of care evolve. The contents of this publication are a guide to clinical practice, based on the best available evidence at the time of development. Adherence to this guide may not ensure a successful outcome in every case, nor should they be construed as including all proper methods of care or excluding other acceptable methods of care. Each physician is ultimately responsible for the management of his/her unique patient in the light of clinical data presented (...) 10 55-59 20 30 20 60-64 40 50 40 65-69 60 100 80 70-74 100 230 170 3 75 320 640 510 Incidence by Age Group (per 100,000)20 3. CLASSIFICATION AND RISK FACTORS 3.1 Primary Osteoporosis • Postmenopausal osteoporosis. Accelerated bone loss related to oestrogen deficiency • Age-related osteoporosis. This occurs in both men and women • Idiopathic (rare) 3.2 Secondary Osteoporosis (See Table 5) Table 5: Secondary Osteoporosis 1. Endocrine • Cushing’s syndrome • Hypogonadism • Thyrotoxicosis

2015 Ministry of Health, Malaysia

300. Management of Cervical Cancer

, based on the best available evidence at the time of development. Adherence to these guidelines may not necessarily guarantee the best outcome in every case. Every healthcare provider is responsible for the management of his/her unique patient based on the clinical picture presented by the patient and the management options available locally. These guidelines were issued in 2015 and will be reviewed in 2019 or sooner if new evidence becomes available. When it is due for updating, the Chairman (...) with lymph node micrometastasis (LNmM), regardless of its size, are considered LVSI positive. LVSI (RR=2.64, 95% CI 1.67 to 5.49) and lymph node micrometastasis (LNmM) 15%) is acceptable when performed in those with FIGO stage III or IV. 28, level II-2 In normal-sized hypermetabolic lymph nodes, the diagnostic value of PET-CT requires further evaluation. 29, level III Fluorodeoxyglucose (FDG) PET/CT is useful for primary evaluation of locally advanced cervical cancer (LACC), monitoring treatment response

2015 Ministry of Health, Malaysia

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