Kooperativer Bibliotheksverbund

UID:

Format: Online Ressource (xviii, 336 p.)

Edition: Online-Ausg. [S.l.] Elsevier 2007 Online-Ressource ScienceDirect

ISBN: 9780126480825 , 0126480826 , 0080454356 , 1280630787 , 9780080454351 , 9781280630781

Content: STROKE AND TRAUMA -- 1. Acute Ischemic Stroke (Christopher Bladin, Stephen Davis) -- 2. Subarachnoid Hemorrhage (Nader Pouratian, Aaron S. Dumont, Neal F. Kassell) -- 3. Spontaneous Intracerebral Hemorrhage (Michael D. Hill) -- 4. Traumatic Brain Injury (Lawrence F. Marshall, Wayne Alves) -- CENTRAL NERVOUS SYSTEM EMERGENCIES -- 5. Acute Seizures and Status Epilepticus (Susan T. Herman) -- 6. Clinical Trials in Neuro-opthamology (Laura Balcer, Madhura A. Tamhankar) -- 7. Brain Resuscitation (Edwin M. Nemoto) -- 8. Clinical Trials in Brain Injury after Cardiac Arrest (Romergryko G. Geocadin, Daniel F. Hanley) -- SPECIAL ISSUES IN ACUTE NEUROSCIENCE CLINICAL TRIALS -- 9. Efficient Dose-Response Finding Strategies for Acute Neuroemergency Treatments (Tom Parke, Michael Krams, Peter Mueller, Don Berry) -- 10. Biostatistical Issues in Neuroemergency Clinical Trials (Wayne M. Alves) -- 11. Data and Safety Monitoring Boards (Brett Skolnick) -- 12. Role of the Project Medical Officer (Joseph Kwentus) -- 13. Ethical Considerations (Wayne Alves) -- PERSPECTIVES ON NEUROEMERGENCY DRUG DEVELOPMENT -- 14. Industry Perspective on Drug Development (Thomas C. Wessel, Chris Gallen) -- 15. Regulatory Considerations (Lisa Travis)

Content: Acute ischemic stroke Christopher Bladin and Stephen Davis -- Subarachnoid hemorrhage Nader Pouratian, Aaron S. Dumont, and Neal F. Kassell -- Spontaneous intracerebral hemorrhage Michael D. Hill -- Traumatic brain injury Wayne M. Alves and Lawrence F. Marshall -- Acute seizures and status epilepticus Susan Herman -- Clinical trials in neuro-ophthalmology Madhura Tamhankar and Laura Balcer -- Brain resuscitation Edwin Nemoto and Charles C. King -- Clinical trials in brain injury after cardiac arrest Romergryko G. Geocadin and Daniel F. Hanley --

Content: Efficient dose-response finding strategies for acute neuroemergency treatments Tom Parke ... [et al.] -- Biostatistical issues in neuroemergency clinical trials Wayne M. Alves -- Data safety and monitoring board: role in acute neurological trials Brett E. Skolnick -- Role of a project medical officer in acute neuroemergency clinical trials Joseph A. Kwentus -- Ethical considerations in neuroemergency clinical trials Wayne M. Alves -- Industry perspective on drug development Thomas C. Wessel and Christopher Gallen -- Regulatory perspective Lisa L. Travis

Content: During the 1990s, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were tested, and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors perspectives. * Presents new perspectives on acute neuroemergency clinical trials * Includes insights from clinical pharmacology and industry perspectives * Discusses historical lessons learned from early and recent trials in acute neuroscience populations

Note: Includes bibliographical references and index. - Description based on print version record , Acute ischemic stroke , Efficient dose-response finding strategies for acute neuroemergency treatments , STROKE AND TRAUMA1. Acute Ischemic Stroke (Christopher Bladin, Stephen Davis) -- 2. Subarachnoid Hemorrhage (Nader Pouratian, Aaron S. Dumont, Neal F. Kassell) -- 3. Spontaneous Intracerebral Hemorrhage (Michael D. Hill) -- 4. Traumatic Brain Injury (Lawrence F. Marshall, Wayne Alves) -- CENTRAL NERVOUS SYSTEM EMERGENCIES -- 5. Acute Seizures and Status Epilepticus (Susan T. Herman) -- 6. Clinical Trials in Neuro-opthamology (Laura Balcer, Madhura A. Tamhankar) -- 7. Brain Resuscitation (Edwin M. Nemoto) -- 8. Clinical Trials in Brain Injury after Cardiac Arrest (Romergryko G. Geocadin, Daniel F. Hanley) -- SPECIAL ISSUES IN ACUTE NEUROSCIENCE CLINICAL TRIALS -- 9. Efficient Dose-Response Finding Strategies for Acute Neuroemergency Treatments (Tom Parke, Michael Krams, Peter Mueller, Don Berry) -- 10. Biostatistical Issues in Neuroemergency Clinical Trials (Wayne M. Alves) -- 11. Data and Safety Monitoring Boards (Brett Skolnick) -- 12. Role of the Project Medical Officer (Joseph Kwentus) -- 13. Ethical Considerations (Wayne Alves) -- PERSPECTIVES ON NEUROEMERGENCY DRUG DEVELOPMENT -- 14. Industry Perspective on Drug Development (Thomas C. Wessel, Chris Gallen) -- 15. Regulatory Considerations (Lisa Travis). , Subarachnoid hemorrhage , Spontaneous intracerebral hemorrhage , Traumatic brain injury , Acute seizures and status epilepticus , Clinical trials in neuro-ophthalmology , Brain resuscitation , Clinical trials in brain injury after cardiac arrest , Biostatistical issues in neuroemergency clinical trials , Data safety and monitoring board: role in acute neurological trials , Role of a project medical officer in acute neuroemergency clinical trials , Ethical considerations in neuroemergency clinical trials , Industry perspective on drug development , Regulatory perspective

Additional Edition: 0126480826

Additional Edition: 0120885239

Additional Edition: Erscheint auch als Druck-Ausgabe Handbook of neuroemergency clinical trials Amsterdam ; Boston : Elsevier Academic Press, ©2006

Language: English

Keywords: Electronic books ; Handbook ; Electronic books

URL: lizenzpflichtig

URL: Volltext

URL: lizenzpflichtig

URL: http://www.loc.gov/catdir/enhancements/fy0623/2005027031-d.html

URL: http://www.loc.gov/catdir/toc/ecip0519/2005027031.html

UID:

Format: XVIII, 336 S. : Ill., graph. Darst.

ISBN: 9780126480825 , 0126480826

Additional Edition: Erscheint auch als Druckausg. Handbook of neuroemergency clinical trials

Language: English

URL: http://www.sciencedirect.com/science/book/9780126480825

UID:

Format: XIV, 226 S.

Note: Zugl.: Univ. of Massachusetts, Diss., 1978

Language: English

Keywords: Hochschulschrift

UID:

Format: XVIII, 336 S. : Ill., graph. Darst.

ISBN: 9780126480825 , 0126480826

Language: English

URL: Inhaltsverzeichnis

UID:

Format: 1 Online-Ressource (408 pages)

Edition: 2nd ed

ISBN: 9780128041017

Content: "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" -- "EtiologyâWhy 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

Content: "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 âSTATE OF PRACTICEâ 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?

Content: "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" -- "PharmacokineticâPharmacodynamic 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 ImagingâDiffusion Tensor Imaging" -- "Functional Magnetic Resonance Imaging" -- "Perfusion Imaging" -- "Magnetic Resonance Spectroscopy" -- "Magnetization Transfer Imaging" -- "Magnetoencephalography" -- "Single-Photon Emission Computed Tomography

Content: "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 SYSTEMâSPECIFIC 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

Content: "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

Content: "CURRENT DISEASE MANAGEMENT AND CONTROVERSIES

Additional Edition: 9780128040645

Additional Edition: Print version Skolnick, Brett E Handbook of Neuroemergency Clinical Trials Saint Louis : Elsevier Science,c2017 9780128040645

Language: English

URL: Volltext  (lizenzpflichtig)

UID:

Format: 1 online resource

Edition: 2nd ed

ISBN: 9780128041017 , 0128041013 , 9780128040645 , 0128040645

Content: Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development

Language: English

Keywords: Nervensystem ; Krankheit ; Neuropharmakologie ; Klinisches Experiment ; Notfallmedizin

URL: Volltext  (URL des Erstveröffentlichers)

URL: Volltext  (URL des Erstveröffentlichers)

UID:

Format: 1 online resource (360 p.)

ISBN: 1-280-63078-7 , 9786610630783 , 0-08-045435-6

Content: During the 1990's, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were "tested,? and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical

Note: Description based upon print version of record. , Acute ischemic stroke / Christopher Bladin and Stephen Davis -- Subarachnoid hemorrhage / Nader Pouratian, Aaron S. Dumont, and Neal F. Kassell -- Spontaneous intracerebral hemorrhage / Michael D. Hill -- Traumatic brain injury / Wayne M. Alves and Lawrence F. Marshall -- Acute seizures and status epilepticus / Susan Herman -- Clinical trials in neuro-ophthalmology / Madhura Tamhankar and Laura Balcer -- Brain resuscitation / Edwin Nemoto and Charles C. King -- Clinical trials in brain injury after cardiac arrest / Romergryko G. Geocadin and Daniel F. Hanley -- , Efficient dose-response finding strategies for acute neuroemergency treatments / Tom Parke ... [et al.] -- Biostatistical issues in neuroemergency clinical trials / Wayne M. Alves -- Data safety and monitoring board: role in acute neurological trials / Brett E. Skolnick -- Role of a project medical officer in acute neuroemergency clinical trials / Joseph A. Kwentus -- Ethical considerations in neuroemergency clinical trials / Wayne M. Alves -- Industry perspective on drug development / Thomas C. Wessel and Christopher Gallen -- Regulatory perspective / Lisa L. Travis.

Additional Edition: ISBN 0-12-804101-3

Additional Edition: ISBN 0-12-648082-6

Language: English

UID:

Format: Online Ressource (3288 KB, 360 S.)

Edition: 1. Aufl.

ISBN: 0126480826

Content: During the 1990's, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were tested, and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors' perspectives. * Presents new perspectives on acute neuroemergency clinical trials * Includes insights from clinical pharmacology and industry perspectives * Discusses historical lessons learned from early and recent trials in acute neuroscience populations

Note: Description based upon print version of record , Handbook of Neuroemergency Clinical Trials; Handbook of Neuroemergency Clinical Trials; Contents; Foreword; Acknowledgments; Introduction; Contributors; Chapter 1: Acute Ischemic Stroke; Stroke Thrombolysis; Antithrombotic Drugs; Neuroprotective Drugs in Acute Ischemic Stroke; Stumbling from the Bench to Bedside; Future Stroke Trials: The Stroke Therapy Academic Industry Roundtable; Conclusions; References; Chapter 2: Subarachnoid Hemorrhage; Etiology, Epidemiology, and Natural History; Diagnosis, Definition of Subpopulations, and Outcomes Assessment; Current Management of Aneurysmal Sah , Novel, Investigational, and Failed TherapeuticsBiological Markers, Surrogate Endpoints, and Outcomes; Why Do So Many Clinical Trials Fail?; Emergent Clinical Technologies and Methodologies; Conclusion; References; Chapter 3: Spontaneous Intracerebral Hemorrhage; Why Acute Ich Clinical Trials Are Difficult; Animal Models: Relevant Issues for Clinical Development Programs; Epidemiology and Natural History; Diagnosis and Subpopulations; Current Disease Management; Issues in Clinical Protocol Development; Outcomes; Efficacy Evaluation; Gold Standard Measures; Surrogate Endpoints , Safety EvaluationReferences; Chapter 4: Traumatic Brain Injury; Historical Context of Traumatic Brain Injury Clinical Trials; Drug Development Programs for Traumatic Brain Injury; Traumatic Brain Injury Drugs and Treatments; Early Clinical Trials of Drugs and Biologics for Traumatic Brain Injury; Why Have Traumatic Brain Injury Clinical Trials Proved Difficult?; Current Environment of Traumatic Brain Injury Drug Development; Key Issues in Traumatic Brain Injury Clinical Trials Design and Analysis; Improved Classifications of Traumatic Brain Injury Populations; Damage and Outcome Measures , Shape of Outcome DistributionPharmacokinetic- Pharmacodynamic Correlations; Censoring Treatment Populations; Conclusion; References; Chapter 5: Acute Seizures and Status Epilepticus; Definitions; Animal Models: Relevant Issues for Clinical Development Programs; Epidemiology and Natural History; Mechanisms of Disease and Pathology; Diagnosis and Subpopulations; Current Disease Management and Controversies; Issues in Clinical Protocol Development; Outcome Measures; Surrogate Endpoints; Safety Evaluation; Conclusion; References; Chapter 6: Clinical Trials in Neuro-Ophthalmology , Optic Neuritis Treatment TrialIschemic Optic Neuropathy Decompression Trial; References; Chapter 7: Brain Resuscitation; Epidemiology and Natural History; Diagnosis and Subpopulations; Current Disease Management; Issues of Clinical Therapeutic Protocol Development; Outcomes of Resuscitation; Gold and Silver Standards; Conclusion; References; Chapter 8: Clinical Trials in Brain Injury After Cardiac Arrest; Epidemiology; Research and Practice Initiatives; Pathophysiology; Secondary Brain Injuries After Cardiac Arrest; Future Directions; Clinical Education and Trial Networks; References , Chapter 9: Efficient Dose-Response Finding Strategies for Acute Neuroemergency Treatments

Additional Edition: 0080454356

Additional Edition: 9780080454351

Additional Edition: Erscheint auch als Druck-Ausgabe Handbook of Neuroemergency Clinical Trials

Language: English

Keywords: Electronic books

URL: Volltext

UID:

Format: 1 Online-Ressource

Edition: 2nd ed

Edition: Online-Ausg.

ISBN: 0128040645 , 0128041013 , 9780128040645 , 9780128041017

Content: Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development

Additional Edition: 0128040645

Additional Edition: 9780128040645

Additional Edition: Erscheint auch als Druck-Ausgabe 0128040645

Additional Edition: 9780128040645

Language: English

Keywords: Electronic book ; Handbook

URL: Volltext

URL: lizenzpflichtig

UID:

Format: 1 online resource (408 pages)

Edition: 2nd ed.

ISBN: 0-12-804064-5

Note: 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.

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