Handbook of Neuroemergency Clinical Trials

• Autore: Skolnick Brett E
• Pubblicazione: Saint Louis : , : Elsevier Science & Technology, , 2017; ©2018
• Edizione: 2nd ed.
• Descrizione fisica: 1 online resource (408 pages)
• Disciplina: 616.8/0461
• Soggetto topico: Nervous system - Diseases; Neuropharmacology; Clinical trials
• Altri autori: AlvesWayne M
• Nota di contenuto: Front Cover -- HANDBOOK OF NEUROEMERGENCY CLINICAL TRIALS -- HANDBOOK OF NEUROEMERGENCY CLINICAL TRIALS -- Copyright -- Dedications -- Contents -- List of Contributors -- Introduction -- CURRENT STATUS OF TREATMENT OF NEUROEMERGENCIES -- ACUTE NEUROCLINICAL TRIALS -- PURPOSE OF THIS VOLUME -- References -- 1 - ACUTE ISCHEMIC STROKEPARTI -- 1 - Acute Ischemic Stroke -- INTRODUCTION -- TRIALS OF REPERFUSION THERAPIES FOR ISCHEMIC STROKE -- Stroke Alteplase Thrombolysis Trials -- The NINDS tPA Trial -- ECASS 1 and 2 Trials -- ATLANTIS Trial -- ECASS 3 Trial -- EPITHET Trial -- IST-3 Trial -- Metaanalyses of Thrombolysis Trials -- Phase 4 Data: Postmarketing Studies in Alteplase Stroke Thrombolysis -- Future Priorities -- Implementation -- Ongoing Trials and Future Directions -- Endovascular Revascularization Trials -- Early Mechanical Thrombectomy Trials -- Endovascular Thrombectomy Using Stent Retrievers -- Metaanalyses of Thrombectomy Trials -- Major Unresolved Questions Around Endovascular Thrombectomy -- ANTITHROMBOTIC DRUGS -- NEUROPROTECTIVE DRUGS IN ACUTE ISCHEMIC STROKE -- STUMBLING FROM THE BENCH TO BEDSIDE -- PHYSIOLOGICAL MODIFICATION OF THE ISCHEMIC ENVIRONMENT -- CONCLUSIONS -- References -- 2 - Subarachnoid Hemorrhage -- CHARACTERISTICS OF THE DISEASE -- Etiology-Why Do Studies Restrict Inclusion to Aneurysmal Subarachnoid Hemorrhage? -- Pathophysiology Considerations Relevant to Clinical Trials -- Clinical Features and Diagnosis -- GUIDELINES FOR MANAGEMENT OF SUBARACHNOID HEMORRHAGE -- SUCCESSES AND DISAPPOINTMENTS -- Ineffective Interventions -- Treatment Side Effects -- Sample Size and Outcome Measures -- The Quagmire of Rescue Therapy -- Center Variation and Practice Misalignment -- Multifactorial Nature of Delayed Cerebral Ischemia and Prognostic Factors for Outcome -- SUBPOPULATIONS AND OUTCOMES AND THEIR ASSESSMENT. ; BIOMARKERS AND SURROGATE ENDPOINTS -- PHARMACOKINETICS AND PHARMACODYNAMICS -- CONSENSUS REGARDING FAILURES AND POSSIBLE SOLUTIONS -- CURRENT "STATE OF PRACTICE" IN DESIGN AND ANALYSIS OF RANDOMIZED CONTROLLED TRIALS FOR SUBARACHNOID HEMORRHAGE -- Disclosures -- References -- 3 - Clinical Trials in Spontaneous Intracerebral Hemorrhage -- INTRODUCTION -- HEMATOMA GROWTH -- Blood Pressure -- Hemostasis -- NEUROPROTECTION -- Cerebral Edema -- Neuroinflammation -- Iron Toxicity/Chelation -- Apoptosis -- Cryoprotection -- SURGERY -- CONCLUSIONS -- References -- 4 - Imaging Biomarkers in Stroke Trials -- INTRODUCTION AND DESCRIPTION OF IMAGING BIOMARKERS -- IMAGING OF INTRALUMINAL THROMBUS -- VASCULAR IMAGING -- COLLATERAL ARTERIAL SUPPLY -- ISCHEMIC CORE AND PENUMBRA -- PREDICTIVE VERSUS PROGNOSTIC BIOMARKERS -- UTILITY OF IMAGING BIOMARKERS -- CONCLUSIONS AND FUTURE DIRECTIONS -- References -- II - TRAUMATIC BRAIN INJURY -- 5 - Traumatic Brain Injury -- INTRODUCTION -- HISTORICAL CONTEXT OF TRAUMATIC BRAIN INJURY TRIALS -- DRUG DEVELOPMENT PROGRAMS FOR TRAUMATIC BRAIN INJURY -- Underlying Logic of Traumatic Brain Injury Trials -- Classes of Novel Drugs Tested in Traumatic Brain Injury -- DRUGS AND TREATMENTS TESTED TO DATE FOR TRAUMATIC BRAIN INJURY -- Barbiturates -- High-Dose Corticosteroids -- Tromethamine (THAM) -- ION CHANNEL BLOCKERS -- Free Radical Scavengers -- Glutamate Antagonists -- Glutamate Agonists -- CDP-Choline -- Immune System Modulators -- Statins -- Progesterone -- Hypothermia -- WHY HAVE TRAUMATIC BRAIN INJURY TRIALS PROVEN TO BE SO DIFFICULT? -- KEY ISSUES IN TRAUMATIC BRAIN INJURY CLINICAL TRIAL DESIGN -- Multiplicity of Injuries -- Anatomic Classification of Traumatic Brain Injury -- Treatment-Related Problems -- Limitations of Traumatic Brain Injury Classification -- Limitations of the Outcome Measures -- Glasgow Coma Scale. ; CT Classification of Traumatic Brain Injury Population -- Prognostic Factors -- Glasgow Outcome Scale -- Outcomes in Traumatic Brain Injury Clinical Trials -- Time Course of Recovery -- Respecifying the Glasgow Outcome Scale -- Shape of Outcome Distribution -- Pharmacokinetic-Pharmacodynamic Correlations -- Censoring Treatment Populations -- CONCLUSIONS -- References -- 6 - Improving Approaches to Evaluate Efficacy and Safety of Drugs for Traumatic Brain Injury -- TRANSLATIONAL APPROACHES -- Extended Experimental Studies -- Better Characterization of Disease Biology and Drug Distribution in Human Traumatic Brain Injury -- IMPROVING TRIAL DESIGN AND ANALYSIS -- Heterogeneity and Statistical Power -- Heterogeneity and Risk of Imbalances -- Dealing With Heterogeneity in Efficacy Analysis -- ALTERNATIVE STRATEGIES TO EXPLORING CLINICAL EFFICACY -- References -- 7 - Brain Imaging in Traumatic Brain Injury -- INTRODUCTION -- TYPES OF BRAIN INJURIES -- Primary Injuries -- Secondary Injuries -- CLASSIFICATION OF TRAUMATIC BRAIN INJURY -- Imaging Modalities -- Conventional Radiography -- Ultrasound -- Computed Tomography -- Computed Tomography Angiography -- Conventional Magnetic Resonance Imaging -- Advanced Techniques -- Diffusion Weighted Imaging-Diffusion Tensor Imaging -- Functional Magnetic Resonance Imaging -- Perfusion Imaging -- Magnetic Resonance Spectroscopy -- Magnetization Transfer Imaging -- Magnetoencephalography -- Single-Photon Emission Computed Tomography -- Positron Emission Tomography -- IMPLICATIONS AND CHALLENGES FOR CLINICAL TRIALS -- CONCLUSION -- References -- 8 - The Use of Blood-Based Biomarkers to Improve the Design of Clinical Trials of Traumatic Brain Injury -- INTRODUCTION -- Traumatic Brain Injury Diagnostics -- Traumatic Brain Injury Management. ; Recent Successes and Disappointments of Clinical Trials for Novel Drugs to Treat Traumatic Brain Injury Management -- Promises of Biomarker Applications in Traumatic Brain Injury Clinical Trials -- SUMMARY OF SEARCH OF CLINICAL TRIALS IN TRAUMATIC BRAIN INJURY USING BIOMARKERS -- SURROGATE ENDPOINTS AND SELECTION OF CENTRAL NERVOUS SYSTEM-SPECIFIC PROTEIN BIOMARKERS FOR SEVERE TRAUMATIC BRAIN INJURY DIAGNO... -- Biomarkers Potentially Useful in Traumatic Brain Injury Trials -- Biomarkers of Glial Injury -- Glial Fibrillary Acidic Protein -- S100 Calcium Binding Protein B (S100B) -- Biomarkers of Neuronal Injury -- Ubiquitin Carboxy-Terminal Hydrolase L1 -- αII-Spectrin Breakdown Products 120, 145, and 150 (SBDP120, SBDP145, SBDP150) -- Microtubule-Associated Protein 2 -- Myelin Basic Protein and Its Autoantibody -- Neuron-Specific Enolase -- Neurofilaments -- Total Tau and Its Cleaved Forms -- Biomarkers of Inflammation and Vascular Injury -- Cytokines -- Cell Adhesion Molecules -- Other Biomarkers -- MicroRNAs -- DISCUSSION -- Improving of the Study Design Using Blood-Based Biomarkers and Their Combination With Other Outcomes Measures -- Statistical Considerations in Clinical Trials Using Biomarker Studies -- PROSPECTS AND PATHWAYS FOR INCORPORATION OF BLOOD-BASED BIOMARKERS INTO THE DESIGN OF CLINICAL TRIALS FOR TRAUMATIC BRAIN INJURY... -- References -- 9 - Biostatistical Issues in TBI Clinical Trials -- INTRODUCTION -- CLINICAL TRIAL DESIGN -- Dose-Finding Designs -- Selection Designs -- Futility Designs -- Confirmatory Designs -- Adaptive Designs -- APPROACHES TO RANDOMIZATION -- Achieving Balance With Respect to Known Prognostic Variables -- Covariate-Adaptive Randomization -- Response-Adaptive Randomization -- Comparing Baseline Characteristics in a Randomized Trial -- OUTCOME MEASURES -- Glasgow Outcome Scale/Glasgow Outcome Scale Extended. ; Performance-Based Measures -- Patient-Reported Outcomes -- Clinician-Reported Outcomes -- Biomarkers -- ANALYTICAL APPROACHES -- The Fixed Dichotomy -- The Sliding Dichotomy -- Ordinal Analysis -- MISSING DATA -- MULTIPLICITY -- SUBGROUP ANALYSIS -- ASSESSMENTS CONDUCTED OVER TIME -- HETEROGENEITY OF THE PATIENT POPULATION -- SUMMARY -- References -- III - SEIZURE EMERGENCIES -- 10 - Acute Seizures and Status Epilepticus -- OVERVIEW -- DIAGNOSIS AND DEFINITION OF STATUS EPILEPTICUS -- CLASSIFICATION OF STATUS EPILEPTICUS -- Semiology -- Etiology -- Electroencephalographic Correlates -- Age -- ANIMAL MODELS: RELEVANT ISSUES FOR CLINICAL DEVELOPMENT PROGRAMS -- EPIDEMIOLOGY AND NATURAL HISTORY -- Acute Repetitive Seizures -- Generalized Convulsive Status Epilepticus -- Refractory Status Epilepticus -- Super-refractory Status Epilepticus -- Nonconvulsive Status Epilepticus -- MECHANISMS OF DISEASE AND PATHOLOGY -- DIAGNOSIS AND SUBPOPULATIONS -- Severity of Injury Measures -- Seizure Type -- Level of Consciousness -- Duration -- Response to Treatment (Status Epilepticus Stage) -- Etiology -- Concomitant Medical Illnesses -- Defining Relevant Treatment Populations -- Defining Good and Poor Prognoses -- Relevant Prognostic Factors for Defining Inclusion and Exclusion Criteria -- Subsetting Patients for Planned and Ad Hoc Comparisons -- CURRENT DISEASE MANAGEMENT AND CONTROVERSIES -- Initial Management Steps -- Prevention of Status Epilepticus: Acute Repetitive Seizures -- Generalized Convulsive Status Epilepticus -- Early Status Epilepticus Treatment -- Established Status Epilepticus -- Refractory Status Epilepticus and Super-refractory Status Epilepticus -- Nonconvulsive Status Epilepticus -- Specific Drugs -- ISSUES IN CLINICAL PROTOCOL DEVELOPMENT -- Time to Treatment -- Operational Definitions of Status Epilepticus -- Site Selection -- Sample Size. ; Treatment Selection.
• Titolo autorizzato: Handbook of Neuroemergency Clinical Trials
• ISBN: 0-12-804064-5
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910583058203321
• Lo trovi qui: Univ. Federico II