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113. Guidelines of the International Headache Society for Controlled Clinical Trials in Idiopathic Intracranial Hypertension

Author

Mollan, Susan P., Fraser, Clare L., Digre, Kathleen B., Diener, Hans Christoph, Lipton, Richard B., Juhler, Marianne, Miller, Neil R., Pozo-Rosich, Patricia, Togha, Mansoureh, Brock, Kristian, Dinkin, Marc J., Chan, Carmen K.M., Tassorelli, Cristina, Sinclair, Alex J., Terwindt, Gisela M., Jensen, Rigmor H., Mollan, Susan P., Fraser, Clare L., Digre, Kathleen B., Diener, Hans Christoph, Lipton, Richard B., Juhler, Marianne, Miller, Neil R., Pozo-Rosich, Patricia, Togha, Mansoureh, Brock, Kristian, Dinkin, Marc J., Chan, Carmen K.M., Tassorelli, Cristina, Sinclair, Alex J., Terwindt, Gisela M., and Jensen, Rigmor H.

Abstract

The quality of clinical trials is essential to advance treatment, inform regulatory decisions and meta-analysis. With the increased incidence of idiopathic intracranial hypertension and the emergence of clinical trials for novel therapies in this condition, the International Headache Society Guidelines for Controlled Clinical Trials in Idiopathic Intracranial Hypertension aims to establish guidelines for designing state-of-the-art controlled clinical trials for idiopathic intracranial hypertension., The quality of clinical trials is essential to advance treatment, inform regulatory decisions and meta-analysis. With the increased incidence of idiopathic intracranial hypertension and the emergence of clinical trials for novel therapies in this condition, the International Headache Society Guidelines for Controlled Clinical Trials in Idiopathic Intracranial Hypertension aims to establish guidelines for designing state-of-the-art controlled clinical trials for idiopathic intracranial hypertension.

Published
2023

114. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma

Author

Dimopoulos, Meletios A., Palumbo, Antonio, Corradini, Paolo, Cavo, Michele, Delforge, Michel, Di Raimondo, Francesco, Weisel, Katja C., Oriol, Albert, Hansson, Markus, Vacca, Angelo, Blanchard, María Jesús, Goldschmidt, Hartmut, Doyen, Chantal, Kaiser, Martin, Petrini, Mario, Anttila, Pekka, Cafro, Anna Maria, Raymakers, Reinier, San-Miguel, Jesus, de Arriba, Felipe, Knop, Stefan, Röllig, Christoph, Ocio, Enrique M., Morgan, Gareth, Miller, Neil, Simcock, Mathew, Peluso, Teresa, Herring, Jennifer, Sternas, Lars, Zaki, Mohamed H., and Moreau, Philippe

Published
2016
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116. Cranial Polyneuropathy Secondary to Remote Iophendylate Myelography

Author

Miller, Neil R.

Subjects
Ophthalmology, Case Report, Neurology (clinical)
Abstract

A 68-year-old woman with controlled hypertension, and degenerative joint disease of the spine for which she had undergone several myelograms and three surgeries 30–32 years earlier, presented with a 2 year history of painless, oblique, binocular diplopia. Her prior ophthalmic evaluations were consistent with an isolated left trochlear nerve paresis. She had magnetic resonance imaging (MRI) showing multiple foci of T1-weighted hyperintensities around the midbrain and brainstem thought to represent subarachnoid fat from a ruptured dermoid cyst. An extensive evaluation revealed a left trochlear nerve paresis as well as diminished sensation in the distributions of the first and second divisions of the left trigeminal nerve. Review of her MRI and history of myelograms raised the possibility of focal inflammation from intrathecal iophendylate (Pantopaque®). Repeat MRI was obtained that showed T1-weighted hyperintensities similar to her previous MRI, but in this study, T1-weighted fat suppression imaging also was performed and revealed these foci to be of low signal intensity, consistent with retained iophendylate.

Published
2022

133. POLR3A variants in hereditary spastic paraplegia and ataxia

Author

Gauquelin, Laurence, Tétreault, Martine, Thiffault, Isabelle, Farrow, Emily, Miller, Neil, Yoo, Byunggil, Bareke, Eric, Yoon, Grace, Suchowersky, Oksana, Dupré, Nicolas, Tarnopolsky, Mark, Brais, Bernard, Wolf, Nicole I, Majewski, Jacek, Rouleau, Guy A, Gan-Or, Ziv, and Bernard, Geneviève

Published
2018
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138. Radiation-induced optic neuropathy: a review.

Author

Carey, Andrew R., Page, Brandi R., and Miller, Neil

Abstract

Radiation is a commonly used treatment modality for head and neck as well as CNS tumours, both benign and malignant. As newer oncology treatments such as immunotherapies allow for longer survival, complications from radiation therapy are becoming more common. Radiation-induced optic neuropathy is a feared complication due to rapid onset and potential for severe and bilateral vision loss. Careful monitoring of high-risk patients and early recognition are crucial for initiating treatment to prevent severe vision loss due to a narrow therapeutic window. This review discusses presentation, aetiology, recent advances in diagnosis using innovative MRI techniques and best practice treatment options based on the most recent evidence-based medicine. [ABSTRACT FROM AUTHOR]

Published
2023
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140. The NSIGHT1-randomized controlled trial: rapid whole-genome sequencing for accelerated etiologic diagnosis in critically ill infants

Author

Petrikin, Josh E., Cakici, Julie A., Clark, Michelle M., Willig, Laurel K., Sweeney, Nathaly M., Farrow, Emily G., Saunders, Carol J., Thiffault, Isabelle, Miller, Neil A., Zellmer, Lee, Herd, Suzanne M., Holmes, Anne M., Batalov, Serge, Veeraraghavan, Narayanan, Smith, Laurie D., Dimmock, David P., Leeder, J. Steven, and Kingsmore, Stephen F.

Published
2018
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142. Clinical Validation of Genome Reference Consortium Human Build 38 in a Laboratory Utilizing Next-Generation Sequencing Technologies

Author

Lansdon, Lisa A, primary, Cadieux-Dion, Maxime, additional, Herriges, John C, additional, Johnston, Jeffrey, additional, Yoo, Byunggil, additional, Alaimo, Joseph T, additional, Thiffault, Isabelle, additional, Miller, Neil, additional, Cohen, Ana S A, additional, Repnikova, Elena A, additional, Zhang, Lei, additional, Farooqi, Midhat S, additional, Farrow, Emily G, additional, and Saunders, Carol J, additional

Published
2022
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146. Genomic answers for children: Dynamic analyses of >1000 pediatric rare disease genomes

Author

Cohen, Ana S.A., primary, Farrow, Emily G., additional, Abdelmoity, Ahmed T., additional, Alaimo, Joseph T., additional, Amudhavalli, Shivarajan M., additional, Anderson, John T., additional, Bansal, Lalit, additional, Bartik, Lauren, additional, Baybayan, Primo, additional, Belden, Bradley, additional, Berrios, Courtney D., additional, Biswell, Rebecca L., additional, Buczkowicz, Pawel, additional, Buske, Orion, additional, Chakraborty, Shreyasee, additional, Cheung, Warren A., additional, Coffman, Keith A., additional, Cooper, Ashley M., additional, Cross, Laura A., additional, Curran, Tom, additional, Dang, Thuy Tien T., additional, Elfrink, Mary M., additional, Engleman, Kendra L., additional, Fecske, Erin D., additional, Fieser, Cynthia, additional, Fitzgerald, Keely, additional, Fleming, Emily A., additional, Gadea, Randi N., additional, Gannon, Jennifer L., additional, Gelineau-Morel, Rose N., additional, Gibson, Margaret, additional, Goldstein, Jeffrey, additional, Grundberg, Elin, additional, Halpin, Kelsee, additional, Harvey, Brian S., additional, Heese, Bryce A., additional, Hein, Wendy, additional, Herd, Suzanne M., additional, Hughes, Susan S., additional, Ilyas, Mohammed, additional, Jacobson, Jill, additional, Jenkins, Janda L., additional, Jiang, Shao, additional, Johnston, Jeffrey J., additional, Keeler, Kathryn, additional, Korlach, Jonas, additional, Kussmann, Jennifer, additional, Lambert, Christine, additional, Lawson, Caitlin, additional, Le Pichon, Jean-Baptiste, additional, Leeder, James Steven, additional, Little, Vicki C., additional, Louiselle, Daniel A., additional, Lypka, Michael, additional, McDonald, Brittany D., additional, Miller, Neil, additional, Modrcin, Ann, additional, Nair, Annapoorna, additional, Neal, Shelby H., additional, Oermann, Christopher M., additional, Pacicca, Donna M., additional, Pawar, Kailash, additional, Posey, Nyshele L., additional, Price, Nigel, additional, Puckett, Laura M.B., additional, Quezada, Julio F., additional, Raje, Nikita, additional, Rowell, William J., additional, Rush, Eric T., additional, Sampath, Venkatesh, additional, Saunders, Carol J., additional, Schwager, Caitlin, additional, Schwend, Richard M., additional, Shaffer, Elizabeth, additional, Smail, Craig, additional, Soden, Sarah, additional, Strenk, Meghan E., additional, Sullivan, Bonnie R., additional, Sweeney, Brooke R., additional, Tam-Williams, Jade B., additional, Walter, Adam M., additional, Welsh, Holly, additional, Wenger, Aaron M., additional, Willig, Laurel K., additional, Yan, Yun, additional, Younger, Scott T., additional, Zhou, Dihong, additional, Zion, Tricia N., additional, Thiffault, Isabelle, additional, and Pastinen, Tomi, additional

Published
2022
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147. First-in-human study of the B7-H4 antibody-drug conjugate (ADC) AZD8205 in patients with advanced/metastatic solid tumors.

Author

Meric-Bernstam, Funda, primary, Oh, Do-Youn, additional, Naito, Yoichi, additional, Shimizu, Toshio, additional, Chung, Vincent, additional, Park, Haeseong, additional, Gaillard, Stephanie, additional, Wang, Fujun, additional, Cooper, Zachary A., additional, Kinneer, Krista, additional, Rebelatto, Marlon, additional, Kirby, Lyndon, additional, Luheshi, Nadia, additional, Miller, Neil, additional, Varga, Andreea, additional, and Mileshkin, Linda R., additional

Published
2022
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148. 8. Optical genome mapping analysis of FMR1 expansions in fragile X syndrome

Author

Barseghyan, Hayk, primary, Muggli, Martin, additional, Ramandi, Bahar, additional, Miller, Neil, additional, Zhang, Dong, additional, Lam, Ernest T., additional, Wang, Jian, additional, Wang, Tom, additional, Lee, Joyce, additional, Pang, Andy WC, additional, Sadowski, Henry B., additional, Hastie, Alex R., additional, and Oldakowski, Mark, additional

Published
2022
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149. CYP2C8, CYP2C9, and CYP2C19 Characterization Using Next-Generation Sequencing and Haplotype Analysis: A GeT-RM Collaborative Project

Author

Gaedigk, Andrea, Boone, Erin C., Scherer, Steven E., Lee, Seung-been, Numanagić, Ibrahim, Sahinalp, Cenk, Smith, Joshua D., McGee, Sean, Radhakrishnan, Aparna, Qin, Xiang, Wang, Wendy Y., Farrow, Emily G., Gonzaludo, Nina, Halpern, Aaron L., Nickerson, Deborah A., Miller, Neil A., Pratt, Victoria M., and Kalman, Lisa V.

Subjects
Cytochrome P-450 CYP2C19, Cytochrome P-450 CYP2C8, Genotype, Haplotypes, High-Throughput Nucleotide Sequencing, Humans, Regular Article, Genetic Testing, Alleles, Cytochrome P-450 CYP2C9
Abstract

Pharmacogenetic tests typically target selected sequence variants to identify haplotypes that are often defined by star (∗) allele nomenclature. Due to their design, these targeted genotyping assays are unable to detect novel variants that may change the function of the gene product and thereby affect phenotype prediction and patient care. In the current study, 137 DNA samples that were previously characterized by the Genetic Testing Reference Material (GeT-RM) program using a variety of targeted genotyping methods were recharacterized using targeted and whole genome sequencing analysis. Sequence data were analyzed using three genotype calling tools to identify star allele diplotypes for CYP2C8, CYP2C9, and CYP2C19. The genotype calls from next-generation sequencing (NGS) correlated well to those previously reported, except when novel alleles were present in a sample. Six novel alleles and 38 novel suballeles were identified in the three genes due to identification of variants not covered by targeted genotyping assays. In addition, several ambiguous genotype calls from a previous study were resolved using the NGS and/or long-read NGS data. Diplotype calls were mostly consistent between the calling algorithms, although several discrepancies were noted. This study highlights the utility of NGS for pharmacogenetic testing and demonstrates that there are many novel alleles that are yet to be discovered, even in highly characterized genes such as CYP2C9 and CYP2C19.

Published
2022

150. Elevated perioptic lipocalin-type prostaglandin D synthase concentration in patients with idiopathic intracranial hypertension

Author

Pircher, Achmed, Montali, Margherita, Berberat, Jatta, Huber, Andreas, Miller, Neil R., Mader, Thomas H., Gibson, C. Robert, Neutzner, Albert, Remonda, Luca, Killer, Hanspeter E., Pircher, Achmed, Montali, Margherita, Berberat, Jatta, Huber, Andreas, Miller, Neil R., Mader, Thomas H., Gibson, C. Robert, Neutzner, Albert, Remonda, Luca, and Killer, Hanspeter E.

Abstract

Pircher et al. report significant higher concentrations of lipocalin-type prostaglandin D synthase in the perioptic subarachnoid space compared with the lumbar subarachnoid space. These findings indicate that next to cerebrospinal fluid pressure gradients, biochemical gradients might play a role in the pathophysiology of optic nerve damage in idiopathic intracranial hypertension. The pathophysiology of vision loss and loss of visual field in patients with idiopathic intracranial hypertension with papilloedema is not fully understood. Although elevated CSF pressure induces damage to the optic nerve due to stasis of axoplasmic flow, there is no clear relationship between the severity of papilloedema and CSF pressure. Furthermore, there are cases of purely unilateral papilloedema and cases without papilloedema despite significantly elevated intracranial pressure as well as papilloedema that can persist despite a successfully lowered intracranial pressure. We hypothesize that at least in some of such cases, in addition to purely pressure-induced damage to the optic nerve, the biochemical composition of the CSF in the subarachnoid space surrounding the orbital optic nerve may play a role in the pathogenesis of vision loss. In this retrospective study, we report on lipocalin-type prostaglandin D synthase concentrations in the CSF within the perioptic and lumbar subarachnoid space in 14 patients with idiopathic intracranial hypertension (13 females, mean age 45 +/- 13 years) with chronic persistent papilloedema resistant to maximum-tolerated medical therapy and visual impairment. CSF was collected from the subarachnoid space of the optic nerve during optic nerve sheath fenestration and from the lumbar subarachnoid space at the time of lumbar puncture. CSF was analysed for lipocalin-type prostaglandin D synthase and the concentrations compared between the two sites using nephelometry. The mean lipocalin-type prostaglandin D synthase concentration in the perioptic subarachno

Published
2022
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