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Clinical Index of Stable Febrile Neutropenia

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21. Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Patient

of this article, please visit: www.aace.com/reprints. Copyright © 2013 AACE. AbbreviA tions AACe = American Association of Clinical Endocrinologists; ACs = American College of Surgery; AsMbs = American Association of Metabolic and Bariatric Surgery; bAC = blood alcohol content; beD = binge eating disorder; beL = best evidence level; bMi = body mass index; bPD-Ds = biliopancreatic diversion with duodenal switch; CCs = clinical case series; CK = creatine kinase; CPAP = continuous posi- tive airway pressure; CPG (...) postoperative complication, such as pulmonary embolus (PE) or anastomotic leak (Grade D). In the clinically stable patient, UGI studies (water-soluble contrast followed by thin barium) or com- puted tomography (CT) may be considered to evaluate for anastomotic leaks in suspected patients (Grade C; beL 3). Exploratory laparotomy or laparoscopy is justified in the setting of high clinical suspicion for anastomotic leaks despite a negative study (Grade C; beL 3). The pres- ence of a new sustained pulse rate

2013 American Association of Clinical Endocrinologists

22. KDIGO Clinical Practice Guideline for Acute Kidney Injury

KDIGO Clinical Practice Guideline for Acute Kidney Injury VOLUME 2 | ISSUE 1 | MARCH 2012 http://www.kidney-international.org OFFICIAL JOURNAL OF THE INTERNATIONAL SOCIETY OF NEPHROLOGY KDIGO Clinical Practice Guideline for Acute Kidney Injury KI_SuppCover_2.1.indd 1 KI_SuppCover_2.1.indd 1 2/7/12 12:32 PM 2/7/12 12:32 PMKDIGO Clinical Practice Guideline for Acute Kidney Injury Tables and Figures iv Notice 1 Work Group Membership 2 KDIGO Board Members 3 Reference Keys 4 Abbreviations (...) and Acronyms 5 Abstract 6 Foreword 7 Summary of Recommendation Statements 8 Section 1: Introduction and Methodology 13 Chapter 1.1: Introduction 13 Chapter 1.2: Methodology 17 Section 2: AKI Definition 19 Chapter 2.1: Definition and classification of AKI 19 Chapter 2.2: Risk assessment 23 Chapter 2.3: Evaluation and general management of patients with and at risk for AKI 25 Chapter 2.4: Clinical applications 28 Chapter 2.5: Diagnostic approach to alterations in kidney function and structure 33 Section 3

2012 National Kidney Foundation

23. Metastatic Non-Small-Cell Lung Cancer: ESMO Clinical Practice Guidelines

comparing monthly car- boplatin plus weekly paclitaxel versus single-agent vinorelbine or gemcitabine in patients aged 70–89 years with PS 0–2 has reportedasurvivaladvantageforcombinationtherapy[35]. Bene?t was observed across all subgroups, but increased tox- icity (notably febrile neutropenia and sepsis-related deaths) was observed. Platinum-based chemotherapy is the preferred option for elderly patients with PS 0-1—as well as selected PS2—and adequate organ function, while a single-agent approach (...) Metastatic Non-Small-Cell Lung Cancer: ESMO Clinical Practice Guidelines Metastaticnon-small-celllungcancer(NSCLC):ESMO ClinicalPracticeGuidelinesfordiagnosis,treatment andfollow-up † M.Reck 1,2 ,S.Popat 3,4 ,N.Reinmuth 1,2 ,D.DeRuysscher 5 ,K.M.Kerr 6 ,S.Peters 7 & onbehalfof theESMOGuidelinesWorkingGroup * 1 DepartmentofThoracicOncology,LungenClinic,Grosshansdorf; 2 MemberoftheGermanCenterforLungResearch(DZL),Germany; 3 RoyalMarsdenHospitalNHS FoundationTrust,London; 4

2014 European Society for Medical Oncology

24. Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer Full Text available with Trip Pro

trials [ ]. Most clinicians (including Panel members) use and understand this clinically relevant categorization of “high-risk” in the context of fever and neutropenia. Low-risk patients are clinically defined by neutropenia anticipated to last ≤7 days, are clinically stable, and have no medical comorbid conditions. In addition to this clinical definition, the MASCC has developed a risk assessment scheme and a well-validated scoring method that can identify subgroups of febrile neutropenic patients (...) of the infection risks, diagnostic methods, and antimicrobial therapies required for management of febrile patients through the neutropenic period. Accordingly, algorithmic approaches to fever and neutropenia, infection prophylaxis, diagnosis, and treatment have been established during the past 40 years, guided and modified by clinical evidence and experience over time. The Infectious Diseases Society of America Fever and Neutropenia Guideline aims to provide a rational summation of these evolving algorithms

2010 Infectious Diseases Society of America

25. To Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors

discontinuation or met one of the following criteria: - Common Terminology Criteria for Adverse Events (CTCAE) Grade (Gr) 3 or 4 nonhematologic toxicity (excluding transient transaminitis) - CTCAE Gr 3 or 4 nausea or vomiting that persisted > 5 days despite maximal anti-emetic treatment - CTCAE Gr 4 thrombocytopenia or anemia that persisted > 7 days or required transfusion > 7 days - CTCAE Gr 3 thrombocytopenia with bleeding - CTCAE Gr 4 uncomplicated neutropenia lasting > 7 days - Febrile neutropenia (...) To Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save

2013 Clinical Trials

26. Clinical Practice Guideline for Schizophrenia and Incipient Psychotic Disorder

in the main medicine and psychology databases: Pubmed/Medline, The Cochrane Database of Systematic Reviews, The Cochrane Controlled Trials Register, The Health Technology Assessment Database, Database of Abstracts of Reviews of Effects (DARE), Science Citation Index, Psycinfo, etc., and pages of different organizations, scientific societies, etc., were reviewed. A search was conducted for potential systematic reviews of the scientific evidence (SRSE) and, in some cases, randomised clinical trials (RCT (...) Clinical Practice Guideline for Schizophrenia and Incipient Psychotic Disorder Clinical Practice Guideline for Schizophrenia and Incipient Psychotic Disorder CLINICAL PRACTICE GUIDELINES IN THE NHS. MINISTRY OF HEALTHCARE AND CONSUMER AFFAIRS CLINICAL PRACTICE GUIDELINES FOR SCHIZOPHENIA AND INCIPIENT PSYCHOTIC DISORDER 2 Clinical Practice Guideline for Schizophrenia and Incipient Psychotic Disorder Clinical Practice Guidelines in the NHS Number 2006/05-2 CLINICAL PRACTICE GUIDELINES IN THE NHS

2009 GuiaSalud

27. Prostate cancer: diagnosis and management

to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 22 of 51What are the risks associated with docetaxel treatment? A large UK randomised trial found that: 15 out of 100 people who took docetaxel developed febrile neutropenia (that is, they got a fever because the chemotherapy had reduced their white blood cells' ability to fight infection). 1 out of 100 people who took docetaxel died because of infections that, in the opinion of the investigators, they might (...) , consider a remote follow-up strategy for people with a stable PSA who have had no significant treatment complications, unless they are taking part in a clinical trial that needs formal clinic-based follow-up. [2019] [2019] 1.3.47 Follow up people with prostate cancer who have chosen a watchful waiting regimen with no curative intent in primary care only if protocols for this have been agreed between the local urological cancer MDT and the relevant primary care organisation(s). Measure their PSA

2019 National Institute for Health and Clinical Excellence - Clinical Guidelines

28. Crohn’s disease: management

health and one or more symptoms such as weight loss, fever, severe abdominal pain and usually frequent (3 to 4 or more) diarrhoeal stools daily. People with severe active Crohn's disease may or may not develop new fistulae or have extra-intestinal manifestations of the disease. This clinical definition normally, but not exclusively, corresponds to a Crohn's Disease Activity Index (CDAI) score of 300 or more, or a Harvey-Bradshaw score of 8 to 9 or above. [2010] [2010] 1.2.19 When using the CDAI (...) appropriate. [2010] [2010] 1.2.16 Treatment with infliximab or adalimumab (see recommendations 1.2.12 and 1.2.15) should only be continued if there is clear evidence of ongoing active disease as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary. Specialists should discuss the risks and benefits of continued treatment with patients and consider a trial withdrawal from treatment for all patients who are in stable clinical remission. People who continue

2019 National Institute for Health and Clinical Excellence - Clinical Guidelines

29. Cell-Free Circulating Tumour DNA Blood Testing to Detect EGFR T790M Mutation in People With Advanced Non–Small Cell Lung Cancer

Clinical Evidence March 2020 Ontario Health Technology Assessment Series; Vol. 20: No. 5, pp. 1–176, March 2020 17 Exclusion Criteria • Animal and in vitro studies • Editorials, case reports, conference abstracts, or commentaries Participants Inclusion Criteria • Patients with NSCLC who have an EGFR-sensitizing mutation who have progressed while using first- or second-generation EGFR-tyrosine kinase inhibitor (TKI) therapy Exclusion Criteria • Patients with other types of cancer Index Test (...) : No. 5, pp. 1–176, March 2020 2 ACKNOWLEDGMENTS This report was developed by a multidisciplinary team from the Quality business unit at Ontario Health. The clinical epidemiologist was Anna Lambrinos, the primary health economist was Lindsey Falk, the secondary health economist was Olga Gajic-Veljanoski, the health economics associate was Lucia Cheng, the patient and public partnership analyst was Ammara Shafique, and the medical librarian was Corinne Holubowich. The medical editors were Elizabeth

2020 Health Quality Ontario

30. Management of Poisoning

hyperthermia. Anecdotal case reports have shown improved clinical symptoms with its use (pg 135). Grade D, Level 3 D In the absence of an established toxic dose, the presence of more than mild clinical effects (vomiting, somnolence, mydriasis, diaphoresis, including those consistent with serotonin syndrome) should be used as an indication for emergency department referral, regardless of the dose reportedly ingested. 23 Patients who have unintentional SSRI ingestions and are asymptomatic may stay at home (...) ; olanzapine 10 mg; quetiapine 100 mg; risperidone 25 1 mg; or ziprasidone 80mg) (pg 141). Grade C, Level 3 C Clinical manifestations of typical antipsychotics poisoning generally include neuroleptic malignant syndrome, rigidity, dystonia, fever and widened QRS interval (pg 141). Grade C, Level 2+ D The primary treatment of cardiotoxicity is plasma alkalinisation with sodium bicarbonate and hyperventilation (pg 141). Grade D, Level 4 GPP Patients with altered mental state or persistent tachycardia despite

2020 Ministry of Health, Singapore

31. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children Full Text available with Trip Pro

and Sepsis Investigators (PALISI) and Shock Society. Dr. Peters participates in the UK PICS study group (vice-chair) and has testified as an expert witness in cases of clinical negligence, causation of injuries. Dr. Agus participates in the American Academy of Pediatrics (AAP), Pediatric Academic Societies (PAS), American Pediatric Society, Society for Pediatric Research, and The American Society for Clinical Investigation, and he has testified as an expert witness in cases related to ICU (...) , and a contributor to Up-to-Date. Dr. Cies received funding from Allergan, Merck, Thermo Fisher Scientific, and Atlantic Diagnostic Laboratories (consultant), and he participates in Pediatric Pharmacy Advocacy Group (multiple positions), Society of Infectious Diseases Pharmacists (Vice-Chair of the Inter-organizations Liaison Committee), and the American College of Clinical Pharmacists (member and fellow). Dr. Cruz has testified as an expert witness in cases of children with tuberculosis-related meningitis

2020 Society of Critical Care Medicine

32. A palliative approach to care in the last 12 months of life

of Life Greetings from Doris Grinspun, Chief Executive Officer, Registered Nurses’ Association of Ontario The Registered Nurses’ Association of Ontario (RNAO) is delighted to present the clinical best practice guideline (BPG) A Palliative Approach to Care in the Last 12 Months of Life. Evidence-based practice supports the excellence in service that health providers are committed to delivering every day. We offer our heartfelt thanks to the many stakeholders who make our vision for BPGs a reality (...) documents that include recommendations on specific clinical, healthy work environment and health system topics. They are intended for nurses and members of the interprofessional health team in direct care positions, and for educators, administrators and executives, policy- makers, researchers, and persons G and families with lived experience. BPGs promote consistency and excellence in clinical care, administrative practices, policies, and education, with the aim of achieving optimal health outcomes

2020 Registered Nurses' Association of Ontario

33. Polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant

of the lymphoma, and impact on surrounding tissue. In addition to staging classifications, the International Prognostic Index (IPI) is used for determining initial prognosis in patients with DLBCL at the time of diagnosis. The IPI consists of five clinical predictors that are used to assign patients to one of four different risk categories (low, low-intermediate, high-intermediate and high risk). It is estimated that two-thirds of patients are cured with this first-line therapy. Disease stage (based (...) on the IPI score) and patient age are significant factors affecting survival. Although most DLBCL patients are cured by standard immunochemotherapy, 10-15% of DLBCL are primary refractory and 20-30% relapse (4). Relapsed DLBCL is characterised by the appearance of any new lesion after a documented history of response, while refractory DLBCL is characterised as progressive disease or no response (stable disease) from the start of previous treatment. 1.2 Current clinical practice The recommended first-line

2020 EUnetHTA

34. Autologous hematopoietic cell transplantation for autoimmune diseases

transplantation for MS, SSc, and CD Study Population Treatment Follow- up/outcomes Multiple Sclerosis Burt, 2019 [9] Multiple Sclerosis International Stem Cell Transplant (MIST) Phase III, multi-centre Population: Patients with stable DMT with >2 relapses within the prior 12 mo. and an EDSS score of 2.0 to 6.0 enrolled between 2009 and January 2018 Med. age yrs. (SD) 36 (8.6) Inclusion: relapse-remitting MS according to McDonald criteria, age 18 to 55 years, 2 or more clinical relapses or 1 relapse and MRI (...) events) 0 (-1 to 1), p=0.53 -5.9 (-31.4 to 20.4), p=0.66 Disease flares 5 (7 events) 7 (10 events) Nonflare symptoms 4 (11 events) 1 (2 events) Hematologic 3 (8 events) 0 (0 events) 0 (0 to 0), p=0.27 13.0 (-4.1 to 32.1), p>0.99 Anemia 1 (5 events) 0 (0 events) Neutropenia 2 (2 events) 0 (0 events) Pancytopenia 1 (1 events) 0 (0 events) Fever SAEs 4 (4 events) 1 (1 events) Renal SAEs 2 (2 events) 2 (2 events) Repsiratory SAEs 4 (4 events) 0 (0 events) Other 8 (14 events) 8 (11 events) CYC

2019 Cancer Care Ontario

35. Treatment of Patients with Schizophrenia

index BPRS Brief Psychiatric Rating Scale CATIE Clinical Antipsychotic Trials for Intervention Effectiveness CBT Cognitive-behavioral therapy CBTp Cognitive-behavioral therapy for individuals with psychosis CDC Centers for Disease Control and Prevention CGI Clinical Global Impression CI Confidence interval CrI Credible interval CSC Coordinated specialty care CSG Canadian Schizophrenia Guidelines CYP Cytochrome P450 DISCUS Dyskinesia Identification System - Condensed User Scale DSM Diagnostic (...) to Enhance Quality of Care 11 External Review 13 8 Funding and Approval 13 Glossary of Terms 13 References 18 Disclosures 102 Individuals and Organizations That Submitted Comments 104 Appendices: Review of Research Evidence 107 Appendix A. Clinical Questions 107 Clinical Questions 107 Appendix B. Search Strategies, Study Selection, and Search Results 107 AHRQ Review 107 Treatment of Neurological Side Effects of Antipsychotic Medications 109 Appendix C. Review of Research Evidence Supporting Guideline

2020 American Psychiatric Association

36. Istradefylline (Nourianz) - Parkinson's disease

8.4.3. Electrocardiograms (ECGs) 58 8.4.4. QT 59 8.4.5. Immunogenicity 59 8.5. Analysis of Submission-Specific Safety Issues 59 8.5.1. Impulse Control Disorder 59 8.5.2. Dizziness, Hypotension, Orthostatic Hypotension 61 8.5.3. Falls 62 8.5.4. Effects on Ability to Drive 62 8.5.5. Cardiac Safety 63 8.5.6. Suicide 64 8.5.7. Neutropenia and Neutropenic Sepsis 66 8.5.8. Drug-Drug interactions 67 8.6. Safety Analyses by Demographic Subgroups 67 CDER Clinical Review Template Version date: September 6 (...) Istradefylline (Nourianz) - Parkinson's disease CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022075Orig1s000 CLINICAL REVIEW(S) (b) (4) Clinical Review Natalie Branagan, MD NDA 022075 Nourianz/istradefylline CLINICAL REVIEW Application Type NDA Application Number(s) 022075 Priority or Standard Class 2 Resubmission Submit Date(s) February 27, 2019 Received Date(s) February 27, 2019 PDUFA Goal Date August 27, 2019 Division/Office DNP Reviewer Name(s) Natalie Branagan, MD Review

2019 FDA - Drug Approval Package

37. Axicabtagene ciloleucel (Yescarta) - diffuse large B-cell lymphoma (DLBCL); primary mediastinal large B-cell lymphoma (PMBCL)

dysfunction (e.g. hepatic, renal, cardiac, and pulmonary). In addition worsening of underlying organ pathologies can occur in the setting of CRS. Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered. Diagnosis of CRS requires excluding alternate causes of systemic inflammatory response, including infection. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum (...) 1000 mg intravenously per day for 2 more days; if improves, then manage as above. Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above. Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. Infections and febrile neutropenia Serious infections have been very commonly observed with YESCARTA (see section 4.8). Patients should be monitored for signs and symptoms of infection before, during, and after YESCARTA

2018 European Medicines Agency - EPARs

38. Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Disease or condition 12 2.2 Quality aspects 14 2.2.1 Introduction 14 2.2.2 Active Substance 14 2.2.3 Finished Medicinal Product 18 2.2.4 Discussion on chemical, pharmaceutical and biological aspects 28 2.2.5 Conclusions on the chemical, pharmaceutical and biological aspects 28 2.2.6 Recommendation(s) for future quality development 28 2.3 Non-clinical aspects 28 2.3.1 Pharmacology 29 2.3.2 Pharmacokinetics 30 2.3.3 Toxicology 31 2.3.4 Ecotoxicity/environmental risk assessment 32 2.3.5 Discussion on non (...) -clinical aspects 32 2.3.6 Conclusion on the non-clinical aspects 33 2.4 Clinical aspects 33 2.4.1 Introduction 33 2.4.2 Pharmacokinetics 36 2.4.3 Pharmacodynamics 51 2.4.4 Discussion on clinical pharmacology 51 2.4.5 Conclusions on clinical pharmacology 53 2.5 Clinical efficacy 54 2.5.1 Main study GP17-301 54 2.5.2 Discussion on clinical efficacy 80 2.5.3 Conclusions on the clinical efficacy 83 2.6 Clinical safety 83 2.6.1 Discussion on clinical safety 102 2.6.2 Conclusions on the clinical safety 104

2018 European Medicines Agency - EPARs

39. Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Scientific discussion 12 2.1 Problem statement 12 2.1.1 Disease or condition 12 2.2 Quality aspects 14 2.2.1 Introduction 14 2.2.2 Active Substance 14 2.2.3 Finished Medicinal Product 18 2.2.4 Discussion on chemical, pharmaceutical and biological aspects 28 2.2.5 Conclusions on the chemical, pharmaceutical and biological aspects 28 2.2.6 Recommendation(s) for future quality development 28 2.3 Non-clinical aspects 29 2.3.1 Pharmacology 29 2.3.2 Pharmacokinetics 30 2.3.3 Toxicology 31 2.3.4 Ecotoxicity (...) /environmental risk assessment 32 2.3.5 Discussion on non-clinical aspects 33 2.3.6 Conclusion on the non-clinical aspects 33 2.4 Clinical aspects 34 2.4.1 Introduction 34 2.4.2 Pharmacokinetics 36 2.4.3 Pharmacodynamics 51 2.4.4 Discussion on clinical pharmacology 51 2.4.5 Conclusions on clinical pharmacology 53 2.5 Clinical efficacy 54 2.5.1 Main study GP17-301 54 2.5.2 Discussion on clinical efficacy 80 2.5.3 Conclusions on the clinical efficacy 83 2.6 Clinical safety 83 2.6.1 Discussion on clinical

2018 European Medicines Agency - EPARs

40. Plitidepsin (Aplidin) - Multiple Myeloma

2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 24 2.2.6. Recommendations for future quality development 24 2.3. Non-clinical aspects 24 2.3.1. Introduction 24 2.3.2. Pharmacology 24 2.3.3. Pharmacokinetics 35 2.3.4. Toxicology 37 2.3.5. Ecotoxicity/environmental risk assessment 43 2.3.6. Discussion on non-clinical aspects 44 2.3.7. Conclusion on the non-clinical aspects 45 2.4. Clinical aspects 45 2.4.1. Introduction 45 2.4.2. Pharmacokinetics 47 2.4.3. Pharmacodynamics 56 (...) 2.4.4. Discussion on clinical pharmacology 59 2.4.5. Conclusions on clinical pharmacology 62 2.5. Clinical efficacy 62 2.5.1. Dose response study(ies) 62 2.5.2. Dose finding studies 62 2.5.3. Main study 63 2.5.4. Supportive studies 95 2.5.5. Discussion on clinical efficacy 98 2.5.6. Conclusions on the clinical efficacy 101 2.6. Clinical safety 101 2.6.1. Discussion on clinical safety 125 2.6.2. Conclusions on the clinical safety 128 2.7. Risk Management Plan 128 2.8. Pharmacovigilance 133 2.9. New

2018 European Medicines Agency - EPARs

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