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JAMA Jun 2023
Topics: Diagnostic Tests, Routine; Clinical Trials as Topic; Diagnostic Techniques and Procedures; Treatment Outcome
PubMed: 37338887
DOI: 10.1001/jama.2023.8972 -
Current Treatment Options in Oncology Jul 2021Clinical trials play a critical role in discovering new treatments, but the path to regulatory approval can be cumbersome and time consuming. Efforts to increase the... (Review)
Review
Clinical trials play a critical role in discovering new treatments, but the path to regulatory approval can be cumbersome and time consuming. Efforts to increase the efficiency and interpretability of clinical trials within the neuro-oncology community have focused on standardization of response assessment, development of consensus guidelines for clinical trial conduct, decentralization of clinical trials, removal of barriers to clinical trial accrual, and re-examination of patient eligibility criteria.
Topics: Clinical Trials as Topic; Humans; Medical Oncology; Nervous System Neoplasms; Outcome Assessment, Health Care; Practice Guidelines as Topic; Research Design
PubMed: 34213625
DOI: 10.1007/s11864-021-00875-8 -
Radiology Jul 2008
Review
Topics: Biotechnology; Clinical Trials as Topic; Decision Making; Decision Support Techniques; Diagnostic Imaging; Technology Assessment, Biomedical; Time Factors; United States
PubMed: 18566166
DOI: 10.1148/radiol.2481072190 -
Trials Jan 2018Once the excitement of trial design, grant-writing and award are behind us, the great open expanse of the next few years is filled almost exclusively by trial...
Once the excitement of trial design, grant-writing and award are behind us, the great open expanse of the next few years is filled almost exclusively by trial management, the nitty-gritty of getting stuff done - delivering the goal. The most important members of the trial team now are not the professors and investigators but the trial managers. These trial managers have limited published information to help them make informed decisions about how to handle the day-to-day challenges that trials present. This special series aims to highlight the fact that writing on trial management is important, publishable and that Trials would welcome more of it.
Topics: Access to Information; Attitude of Health Personnel; Clinical Decision-Making; Clinical Trials as Topic; Evidence-Based Medicine; Health Knowledge, Attitudes, Practice; Humans; Information Dissemination; Periodicals as Topic; Research Design; Research Personnel; Writing
PubMed: 29310691
DOI: 10.1186/s13063-017-2322-8 -
Clinical Microbiology and Infection :... Jul 2019
Topics: Biostatistics; Clinical Trials as Topic; Diagnostic Tests, Routine; Humans; Sample Size
PubMed: 30986555
DOI: 10.1016/j.cmi.2019.04.011 -
Seizure Jan 2017Status epilepticus (SE) requires not only urgent symptomatic treatment with antiepileptic drugs but also rapid identification and treatment of its cause. This narrative... (Review)
Review
PURPOSE
Status epilepticus (SE) requires not only urgent symptomatic treatment with antiepileptic drugs but also rapid identification and treatment of its cause. This narrative review summarizes the most important advances in classification and treatment of SE.
METHOD
Data sources included MEDLINE, EMBASE, ClinicalTrials.gov, and back tracking of references in pertinent studies, reviews, and books.
RESULTS
SE is now defined as "a condition resulting either from the failure of the mechanisms responsible for seizure termination or from the initiation of mechanisms, which lead to abnormally, prolonged seizures (after time point t1). It is a condition, which can have long-term consequences (after time point t2), including neuronal death, neuronal injury, and alteration of neuronal networks, depending on the type and duration of seizures." A new diagnostic classification system of SE introduces four axes: semiology, aetiology, EEG correlates, and age. For the acute treatment intravenous benzodiazepines (lorazepam, diazepam, clonazepam) and intramuscular midazolam appear as most effective treatments for early SE. In children, buccal or intranasal midazolam are useful alternatives. In established SE intravenous antiepileptic drugs (phenytoin, valproate, levetiracetam, phenobarbital, and lacosamide) are in use. Treatment options in refractory SE are intravenous anaesthetics; ketamine, magnesium, steroids and other drugs have been used in super-refractory SE with variable outcomes.
CONCLUSION
Over the past 25 years major advances in definition, classification and understanding of its mechanisms have been achieved. Despite this up to 40% of patients in early status cannot be controlled with first line drugs. The treatment of super-refractory status is still an almost evidence free zone.
Topics: Clinical Trials as Topic; Databases, Factual; Electroencephalography; History, 20th Century; History, 21st Century; Humans; Status Epilepticus
PubMed: 27890484
DOI: 10.1016/j.seizure.2016.11.001 -
Hormone and Metabolic Research =... Dec 2017Adrenal vein sampling (AVS) is considered the gold standard for the differential diagnosis in patients with primary aldosteronism (PA). The distinction between... (Review)
Review
Adrenal vein sampling (AVS) is considered the gold standard for the differential diagnosis in patients with primary aldosteronism (PA). The distinction between unilateral and bilateral disease dictates the targeted therapeutic approach with surgery for aldosterone producing adenomas and medical therapy for patients with bilateral hyperplasia. Thereby, this diagnostic step is crucial in clinical care. As AVS is an invasive, not well standardized procedure that is restricted to few specialized centers, several attempts have been made to simplify diagnostic algorithms. In this clinical scenario, the recently published SPARTACUS trial aimed at answering the question whether AVS in fact is superior for differential diagnosis in comparison to imaging of the adrenal glands. In this multicenter study, patients were randomized to be treated according to AVS results or based on abdominal imaging only. Clinical outcome in both patient groups after one year was reported as not different. While the study results found broad interest, it also stirred considerable controversies. This review provides an overview on the different views regarding the outline of the SPARTACUS trial and the interpretation of its results.
Topics: Adrenal Glands; Aldosterone; Blood Specimen Collection; Clinical Trials as Topic; Diagnosis, Differential; Humans; Hyperaldosteronism; Tomography, X-Ray Computed
PubMed: 29165736
DOI: 10.1055/s-0043-120524 -
The Quarterly Journal of Nuclear... Dec 2019In radiomics, quantitative features that describe phenotypic tumor characteristics are derived from radiographic images. Because radiomics generates information from... (Review)
Review
In radiomics, quantitative features that describe phenotypic tumor characteristics are derived from radiographic images. Because radiomics generates information from routine medical images, it is a powerful way to non-invasively examine the spatial and temporal heterogeneity of disease, and thus has potential to significantly impact clinical trial design, execution, and ultimately patient care. The aim of this review article is to discuss how radiomics may address some of the current challenges in clinical randomized control trials, and the difficulties of integrating robust and repeatable radiomics analysis into trial design. Each step of the radiomics process, including image acquisition and reconstruction, image segmentation, feature extraction, and computational analysis, requires extensive standardization in order to be successfully incorporated into clinical trials and inform clinical decision making. By addressing these challenges, the potential of radiomics may be realized.
Topics: Clinical Trials as Topic; Diagnostic Imaging; Humans; Image Processing, Computer-Assisted; Neoplasms
PubMed: 31527581
DOI: 10.23736/S1824-4785.19.03217-5 -
The Lancet. Oncology Mar 2015
Topics: Clinical Trials as Topic; Comorbidity; Eligibility Determination; Humans; Neoplasms; Patient Selection; Risk Factors; Selection Bias; Treatment Outcome
PubMed: 25752544
DOI: 10.1016/S1470-2045(15)70089-6 -
Epilepsy & Behavior : E&B Dec 2019Convulsive status epilepticus (SE) is a relatively common emergency condition affecting individuals of all ages. The primary goal of treatment is prompt termination of... (Review)
Review
Convulsive status epilepticus (SE) is a relatively common emergency condition affecting individuals of all ages. The primary goal of treatment is prompt termination of seizures. Where first-line treatment with benzodiazepine has failed to achieve this, a condition known as established SE (ESE), there is uncertainty about which agent to use next. The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE. Enrollment was completed in January 2019, and the results are expected later this year. We discuss lessons learnt during the conduct of the study in relation to the following: ethical considerations; trial design and practical implementation in emergency settings, including pediatric and adult populations; quality assurance; and outcome determination where treating emergency clinicians may lack specialist expertise. We consider that the ESETT is already informing both clinical practice and future trial design. This article is part of the Special Issue "Proceedings of the 7th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures".
Topics: Adult; Anticonvulsants; Benzodiazepines; Child, Preschool; Clinical Trials as Topic; Diagnostic Tests, Routine; Double-Blind Method; Emergency Service, Hospital; Female; Humans; Levetiracetam; Male; Status Epilepticus; Treatment Outcome; Valproic Acid
PubMed: 31653603
DOI: 10.1016/j.yebeh.2019.04.049